Medical injector simulation device and containers for storing delivery devices

ABSTRACT

An apparatus includes a simulated medicament delivery device and an electronic circuit system coupled to the simulated medicament delivery device. The electronic circuit system is configured to output an electronic output associated with a use of the simulated medicament delivery device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/593,630, entitled “Medical Injector Simulation Device,” filed Jan. 9,2015, which is a continuation of U.S. patent application Ser. No.11/679,331, now U.S. Pat. No. 9,022,980, entitled “Medical InjectorSimulation Device,” filed Feb. 27, 2007, both of which are incorporatedherein by reference in their entirety. U.S. patent application Ser. No.11/679,331, now U.S. Pat. No. 9,022,980, is related to U.S. patentapplication Ser. No. 11/671,025, now U.S. Pat. No. 8,172,082, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Feb. 5,2007, which is a continuation-in-part of U.S. patent application Ser.No. 11/621,236, now U.S. Pat. No. 7,731,686, entitled “Devices, Systemsand Methods for Medicament Delivery,” filed Jan. 9, 2007, which is acontinuation-in-part of U.S. patent application Ser. No. 10/572,148, nowU.S. Pat. No. 7,749,194, entitled “Devices, Systems and Methods forMedicament Delivery,” filed Mar. 16, 2006, which is a national stagefiling under 35 U.S.C. § 371 of International Patent Application No.PCT/US2006/003415, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Feb. 1, 2006, which claims priority to U.S. ProvisionalApplication Ser. No. 60/648,822, entitled “Devices, Systems and Methodsfor Medicament Delivery,” filed Feb. 1, 2005 and U.S. ProvisionalApplication Ser. No. 60/731,886, entitled “Auto-Injector with Feedback,”filed Oct. 31, 2005, each of which is incorporated herein by referencein its entirety. U.S. patent application Ser. No. 11/679,331 claimspriority to U.S. Provisional Application Ser. No. 60/787,046, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Mar. 29,2006, which is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to a medical device, and moreparticularly to a simulated medicament delivery device.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure. Becauseemergency medical facilities may not be available when an individual issuffering from an allergic reaction, some individuals carry a medicamentdelivery device, such as, for example, an auto-injector, to rapidlyself-administer a medicament in response to an allergic reaction.

To actuate such a medicament delivery device, however, the user may berequired to execute a series of operations. For example, to actuate someknown auto-injectors, the user must remove a protective cap, remove alocking device, place the auto-injector in a proper position against thebody and then press a button to actuate the auto-injector. Failure tocomplete these operations properly can result in an incomplete injectionand/or injection into an undesired location of the body. In certaininstances, for example, users who have become confused in the operationof some known auto-injectors have inadvertently injected the medicamentinto their thumb by improperly positioning the auto-injector.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, and may therefore have no experience with the medicamentdelivery device. Similarly, because some known medicament deliverydevices are configured to be used relatively infrequently in response toan allergic reaction or the like, even those users familiar with thedevice and/or who have been trained may not be well practiced atoperating the device. Finally, such devices are often used during anemergency situation, during which even experienced and/or trained usersmay be subject to confusion, panic and/or the physiological effects ofthe condition requiring treatment.

Some known medicament delivery devices include printed instructions toinform the user of the steps required to properly deliver themedicament. Such printed instructions, however, can be inadequate forthe class of users and/or the situations described above. Moreover,because some known medicament delivery devices, such as, for example,auto-injectors, pen injectors, inhalers or the like, can be compact,such printed instructions may be too small to read and comprehend duringan emergency situation.

Some known medicament delivery devices are associated with simulatedmedicament delivery devices (e.g., “trainers”) to provide a method forusers to practice using the medicament delivery device without beingexposed to the medicament or needles typically contained therein. Suchsimulated medicament delivery devices, however, can also includeinadequate use instructions as described above. Moreover, some knownsimulated medicament delivery devices can be difficult to reset forsubsequent use.

Thus, a need exists for a simulated medicament delivery device thatprovides instructions that can be easily understood by an untrained userin any type of situation. Additionally, a need exists for a simulatedmedicament delivery device that can be easily reset for subsequent use.

SUMMARY

Medicament delivery devices are described herein. In some embodiments,an apparatus includes a simulated medicament delivery device and anelectronic circuit system coupled to the simulated medicament deliverydevice. The electronic circuit system is configured to output anelectronic output associated with a use of the simulated medicamentdelivery device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a medicament delivery device accordingto an embodiment of the invention.

FIG. 2 is a front cross-sectional view of the medicament delivery deviceshown in FIG. 1.

FIG. 3 is a schematic illustration of a portion of the medicamentdelivery device shown in FIG. 1.

FIG. 4 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIG. 5 is a perspective view of an auto-injector according to anembodiment of the invention.

FIG. 5A is a perspective view of the auto-injector illustrated in FIG. 5in a first configuration, with at least a portion of the auto-injectorillustrated in phantom lines for ease of reference.

FIG. 5B is a front view of the auto-injector illustrated in FIGS. 5 and5A in a first configuration.

FIG. 5C is a top view of the housing of the auto-injector shown in FIG.5.

FIG. 5D is a cross-sectional view of the housing taken along line 5D-5Din FIG. 5C.

FIG. 5E is a perspective view of the auto-injector illustrated in FIG. 5showing an assembly according to an embodiment being removed.

FIG. 5F is a front view of the auto-injector illustrated in FIG. 5showing a member according to an embodiment being removed.

FIG. 5G is an exploded perspective view of a portion of theauto-injector illustrated in FIG. 5.

FIG. 5H is a cross-sectional view of a needle sheath illustrated in FIG.5G.

FIG. 5I is a perspective view of a retainer illustrated in FIG. 5G.

FIG. 5J is a perspective view of the member of the auto-injectorillustrated in FIG. 5F.

FIG. 5K is a perspective view of a portion of the auto-injectorillustrated in FIG. 5.

FIG. 5L is a perspective view of a portion of the auto-injectorillustrated in FIG. 5.

FIG. 5M is a partially exploded perspective view of a base of theauto-injector illustrated in FIG. 5K.

FIG. 5N is a front view of the auto-injector illustrated in FIG. 5 in asecond configuration.

FIG. 6 is a front view of the auto-injector illustrated in FIG. 5, witha portion of the auto-injector illustrated in phantom lines for ease ofreference.

FIG. 7 is a partial cut-away front view of a portion of theauto-injector illustrated in FIG. 5.

FIG. 8 is a cross-sectional view of a portion of the auto-injectorillustrated in FIG. 5 taken along line 8-8 in FIG. 7.

FIG. 9 is a cross-sectional view of a portion of the auto-injectorillustrated in FIG. 5 taken along line 9-9 in FIG. 7.

FIG. 10 is a front view of a portion of the auto-injector illustrated inFIG. 5.

FIG. 11 is a schematic illustration of a portion of the auto-injectorillustrated in FIG. 5.

FIG. 12 is a perspective view of a portion of the auto-injectorillustrated in FIG. 5 in a second configuration.

FIG. 13 is a perspective view of a portion of the auto-injectorillustrated in FIG. 5 in a third configuration.

FIG. 14 is a perspective view of a portion of the auto-injectorillustrated in FIG. 5 in a fourth configuration.

FIGS. 15 and 16 are front views of a portion of the auto-injectorlabeled as region 15 in FIG. 10, in a first configuration and a secondconfiguration, respectively.

FIGS. 17 through 20 are perspective views of a portion of theauto-injector illustrated in FIG. 10, in a first configuration, a secondconfiguration, a third configuration and a fourth configuration,respectively.

FIG. 21 is a flow chart of a method according to an embodiment of theinvention.

FIG. 22 is a flow chart of a method according to an embodiment of theinvention.

FIG. 23 is a flow chart of a method according to an embodiment of theinvention.

FIGS. 24 and 25 are perspective views of a medicament delivery deviceaccording to an embodiment of the invention.

FIGS. 26-28 are schematic illustrations of a medical device according toan embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively.

FIGS. 29-31 are schematic illustrations of a medical device according toan embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively.

FIG. 32 is a schematic illustration of a medical device according to anembodiment of the invention.

FIG. 33 is a perspective view of a medical device according to anembodiment of the invention in a first configuration.

FIG. 34 is a perspective view of the medical device shown in FIG. 33 ina second configuration.

FIG. 35 is a perspective view of the medical device shown in FIG. 33 ina third configuration.

FIG. 36 is a schematic illustration of a portion of a medical deviceaccording to an embodiment of the invention.

FIGS. 37-39 are schematic illustrations of a medical device according toan embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively.

FIG. 40 is a schematic illustration of a simulated medicament deliverydevice according to an embodiment of the invention.

FIG. 41 is a perspective view of a simulated auto-injector according toan embodiment of the invention.

FIGS. 42-46 are front are front views of a simulated auto-injectoraccording to an embodiment of the invention, in a first configuration,second configuration, third configuration, fourth configuration andfifth configuration, respectively.

FIG. 47 is a schematic illustration of a medical device according to anembodiment of the invention.

FIG. 48 is a schematic illustration of a medical device according to anembodiment of the invention.

FIG. 49 is a perspective view of a simulated medicament delivery deviceaccording to an embodiment of the invention

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a label configured to becoupled to a medicament delivery device and/or a simulated medicamentdelivery device. The label includes a first surface and a secondsurface. The first surface is configured to be coupled to an outersurface of the medicament delivery device and/or the simulatedmedicament delivery device. In some embodiments, for example, the firstsurface can include an adhesive. The second surface includes a textualindicia, such as, for example, a description of the medicament deliverydevice, a mark indicating the manufacturer or distributor of themedicament delivery device and/or an instruction associated with the useof the medicament delivery device. The label further includes anelectronic circuit system configured to output an electronic signal. Insome embodiments, the electronic signal can include an instructionassociated with the use of the medicament delivery device and/or thesimulated medicament delivery device.

In some embodiments, an apparatus includes a printed circuit boardconfigured to be coupled to a medicament delivery device and/or asimulated medicament delivery device. The printed circuit board includesa substrate and an electrical conductor disposed on the substrate. Thesubstrate includes an actuation portion configured to receive anactuator. The actuator is configured to deform the actuation portion ofthe substrate, thereby separating the electrical conductor.

In some embodiments, an apparatus includes a printed circuit boardconfigured to be coupled to a medicament delivery device and/or asimulated medicament delivery device. The printed circuit board includesa substrate and an electrical conductor disposed on the substrate. Thesubstrate includes an actuation portion configured to receive anactuator. The actuation portion of the substrate defines an openingadjacent the electrical conductor, the opening being configured toreceive the actuator. The actuator is configured to move substantiallyparallel to a plane defined by a surface of the actuation portion of thesubstrate to produce a tear in the actuation portion of the substrate,thereby severing the electrical conductor. In some embodiments, theopening can be configured to propagate the tear in a predetermineddirection.

In some embodiments, an apparatus includes a medicament delivery deviceconfigured to deliver a medicament into a body. The medicament deliverydevice, which can be, for example, a pen injector, an auto-injector, aninhaler or a transdermal delivery device, includes an electronic circuitsystem and a locking member. The electronic circuit system is configuredto output an electronic signal associated with a use of the medicamentdelivery device. In some embodiments, the electronic signal can be, forexample, associated with recorded speech. The locking member isconfigured to prevent the medicament from being delivered into the body.The locking member includes an actuator configured to actuate theelectronic circuit system.

In some embodiments, an apparatus includes a medicament delivery deviceconfigured to deliver a medicament into a body. The medicament deliverydevice includes an electronic circuit system and a locking member. Theelectronic circuit system includes a switch and is configured to outputa signal when the switch is moved from a first state to a second state.The locking member is configured to prevent the medicament from beingdelivered into the body when in a first position and to allow themedicament to be delivered into the body when in a second position. Aportion of the locking member is configured to move the switch from thefirst state to the second state when the locking member is moved fromthe first position to the second position.

In some embodiments, an apparatus includes a housing configured tocontain a medicament, a flexible printed circuit board, an energystorage member and a label. The flexible printed circuit board isdisposed on an outer surface of the housing and includes a firstelectrical contact portion and a second electrical contact portion. Thelabel is coupled to the flexible printed circuit board and the housingand is configured to maintain a first surface of the energy storagemember in electrical communication with the first electrical contactportion and maintain a second surface of the energy storage member inelectrical communication with the second electrical contact portion. Theenergy storage member, can be, for example, a battery.

In some embodiments, a method includes assembling a medicament deliverydevice and/or a simulated medicament delivery device, such as, forexample, an auto-injector or an auto-injector simulator. An electroniccircuit system is then placed against an outer surface of the medicamentdelivery device and/or the simulated medicament delivery device. A labelis then coupled to the medicament delivery device and/or the simulatedmedicament delivery device such that the label is disposed about aportion of the electronic circuit system.

In some embodiments, an apparatus includes a container defining aninternal region configured to contain multiple medicament deliverydevices, such as, for example, pen injectors, auto-injectors, inhalersor the like. The container includes an electronic circuit systemconfigured to output a first electronic output associated with a firstmedicament delivery device contained within the internal region when thefirst medicament delivery device is removed from the internal region ofthe container. The electronic circuit system is further configured tooutput a second electronic output associated with a second medicamentdelivery device contained within the internal region when the secondmedicament delivery device is removed from the internal region of thecontainer. The second electronic output is different than the firstelectronic output. At least one of the first electronic output or thesecond electronic output is associated with a use instruction of thefirst medicament delivery device and/or the second medicament deliverydevice.

In some embodiments, an apparatus includes a container defining aninternal region configured to contain multiple medicament deliverydevices. The container includes an electronic circuit system configuredto output a first electronic output associated with a first medicamentdelivery device contained within the internal region when the firstmedicament delivery device is removed from the internal region of thecontainer. The first medicament delivery device includes a labelconfigured to output a signal associated with at least one of a contentsof the first medicament delivery device, an expiration date of the firstmedicament delivery device, a dosage of the first medicament deliverydevice or a use instruction associated with the first medicamentdelivery device. In this manner, the first electronic output can beassociated with the signal received by the electronic circuit system.The electronic circuit system is further configured to output a secondelectronic output associated with a second medicament delivery devicecontained within the internal region when the second medicament deliverydevice is removed from the internal region of the container. The secondelectronic output is different than the first electronic output. Atleast one of the first electronic output or the second electronic outputis associated with a use instruction of the first medicament deliverydevice and/or the second medicament delivery device.

In some embodiments, a kit includes a medicament delivery device and acontainer. The container defines an internal region configured tocontain the medicament delivery device. The container includes a movableportion, an electronic circuit system, a first switch and a secondswitch. The movable portion has a first position, in which the movableportion covers the internal region of the container, and a secondposition, in which the internal region of the container is exposed to anarea outside the container. The first switch is configured to movebetween a first state and a second state when the movable portion movesbetween its first position and its second position. The first switch isoperatively coupled to the electronic circuit system such that theelectronic circuit system is configured to output a first electronicoutput when the first switch is moved from its first state to its secondstate. The first electronic output can be, for example, a visual output,an audible output or a haptic output. The second switch is configured tomove between a first state and a second state when the medicamentdelivery device is removed from the internal region of the container.The second switch is operatively coupled to the electronic circuitsystem such that the electronic circuit system is configured to output asecond electronic output when the second switch is moved from its firststate to its second state. The second electronic output, which includesan instruction for using the medicament delivery device, can be, forexample, a visual output (e.g. a video showing the proper use of themedicament delivery device), an audible output (e.g., a voice recordingproviding instructions for use) or a haptic output (e.g., a vibrationindicating the location of a particular item).

In some embodiments, an apparatus includes a container, a retainer andan electronic circuit system. The container defines an internal regionconfigured to contain at least a portion of a medicament deliverydevice, such as, for example a pen injector. The retainer is configuredto be movably coupled to the container and to retain the portion of themedicament delivery device within the internal region defined by thecontainer. The electronic circuit system is configured to output a firstelectronic output when the retainer is moved relative to the containerand a second electronic output when the medicament delivery device isremoved from the internal region. At least one of the first electronicoutput or the second electronic output is associated with an instructionfor using the medicament delivery device.

In some embodiments, an apparatus includes a container, a retainer, anelectronic circuit system and a label. The container defines an internalregion configured to contain at least a portion of a medicament deliverydevice, such as, for example a pen injector. The retainer is configuredto be movably coupled to the container and to retain the portion of themedicament delivery device within the internal region defined by thecontainer. The label is configured to be coupled to the medicamentdelivery device and contain information associated with the medicamentdelivery device in a machine-readable format. The electronic circuitsystem is configured to output a first electronic output when theretainer is moved relative to the container and a second electronicoutput when the medicament delivery device is removed from the internalregion. The electronic circuit system is further configured to receivethe information contained on the label include at least a portion of theinformation in the first electronic output and/or the second electronicoutput. At least one of the first electronic output or the secondelectronic output is associated with an instruction for using themedicament delivery device.

In some embodiments, an apparatus includes a simulated medicamentdelivery device and an electronic circuit system coupled to thesimulated medicament delivery device. The simulated medicament deliverydevice can be configured, for example, to simulate the look, feel and/orfunctionality associated with a pen injector, an auto-injector, aninhaler and/or a transdermal delivery device. The electronic circuitsystem is configured to output an electronic output associated with ause of the simulated medicament delivery device. The electronic outputcan include, for example, a signal associated with a visual output, anaudible output, a haptic output, an olfactory output and/or a tasteoutput. Moreover, the electronic output can include, for example, aninstruction for using the simulated medicament delivery device and/or amedicament delivery device.

In some embodiments, an apparatus includes a housing associated with amedicament delivery device and an electronic circuit system. Theelectronic circuit system is coupled to the housing. The housing and theelectronic circuit system are configured to cooperatively simulate themedicament delivery device. The electronic circuit system is configuredto output an electronic output to simulate a tactile sensation, anaudible sensation, a visual sensation, an olfactory sensation and/or ataste sensation associated with a use of the medicament delivery device.

In some embodiments, a kit includes a medicament delivery device and asimulated medicament delivery device. The simulated medicament deliverydevice includes an electronic circuit system configured to output anelectronic output associated with a use of the simulated medicamentdelivery device and/or the medicament delivery device.

In some embodiments, a kit includes a medicament delivery device, asimulated medicament delivery device and a container. The container isconfigured to contain the medicament delivery device and the simulatedmedicament delivery device. The simulated medicament delivery deviceincludes an electronic circuit system configured to output a firstelectronic output associated with a use of at least one of the simulatedmedicament delivery device or the medicament delivery device. Thecontainer includes an electronic circuit system. The electronic circuitsystem of the container and the electronic circuit system of thesimulated medicament delivery device are configured to cooperativelyoutput a second electronic output associated with a use of at least oneof the simulated medicament delivery device or the medicament deliverydevice.

In some embodiments, an apparatus includes a label configured to becoupled to a simulated medicament delivery device. The label includes afirst surface, a second surface and an electronic circuit system. Thefirst surface is configured to be coupled to a housing of the simulatedmedicament delivery device. The second surface includes a textualindicia. The electronic circuit system configured to output anelectronic signal.

FIGS. 1 and 2 are a perspective view and a partial cutaway front view,respectively, of an auto-injector 1002 according to an embodiment of theinvention. The auto-injector 1002 is similar to the auto-injectorsdescribed in U.S. patent application Ser. No. 11/562,061, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Nov. 21,2006, which is incorporated herein by reference in its entirety.Accordingly, only an overview of the mechanical components and relatedoperation of the auto-injector 1002 is included below.

The auto-injector 1002 includes a housing 1110 that defines a gaschamber 1120. The housing 1110 has a proximal end portion 1112 and adistal end portion 1114. A base 1520 is movably coupled to the distalend portion 1114 of the housing 1110. A safety lock 1710 is removablycoupled to the base 1520. As discussed in more detail herein, when thesafety lock 1710 is coupled to the base 1520, the auto-injector 1002cannot be actuated. When the safety lock 1710 is removed from the base1520, the base 1520 can be moved relative to the housing 1110, therebyactuating the auto-injector 1002. Accordingly, to inject a medicamentinto the body, the distal end portion 1114 of the housing 1110 isoriented towards the user such that the base 1520 is in contact with theportion of the body where the injection is to be made. The base 1520 isthen moved towards the proximal end 1112 of the housing 1110 to actuatethe auto-injector 1002.

The auto-injector 1002 includes a medicament injector 1210 and a systemactuator 1510 disposed non-coaxially within the housing 1110. Themedicament injector 1210 includes multiple medicament vials 1262, aplunger 1284 movably disposed within each medicament vial 1262, amovable member 1312 engaged with each plunger 1284 and a needle 1212.Retraction springs 1350 located within a portion of the base 1520 andthe housing 1110 can push the needle 1212 back within the housing 1110after injection. The system actuator 1510 includes a compressed spring1560, a compressed gas cylinder 1412, and a puncturing mechanism 1612 todispel the contents of the compressed gas cylinder 1412.

In use, when the auto-injector 1002 is actuated, the puncturingmechanism 1612 punctures the compressed gas cylinder 1412 allowing apressurized gas to flow into the gas chamber 1120. In response to aforce produced by the pressurized gas on the movable member 1312, themovable member 1312 moves distally within the housing 1110. As a result,the needle 1212 is extended through the housing 1110. The movement ofthe movable member 1312 also causes the plungers 1284 to move within thevials 1262, thereby expelling a medicament from the vials 1262.

The auto-injector 1002 includes an electronic circuit system 1920 toprovide a predetermined sequence of electronic outputs during the use ofthe auto-injector 1002. The electronic circuit system 1920 is powered bya battery (not shown in FIGS. 1 and 2) and includes a processor (notshown in FIGS. 1 and 2), a start button 1970, two switches 1972A and1972B, a proximity sensor 1974, two visual output devices 1958A and1958B and an audio output device 1956. The components of the electroniccircuit system 1920 are operatively coupled by any suitable mechanism,such as, for example, a printed circuit board (not shown in FIGS. 1 and2) having conductive traces.

The start button 1970 is disposed on the proximal end of the housing1110 and can be manually actuated by the user to begin the sequence ofelectronic outputs. The first switch 1972A is disposed on the distalportion 1114 of the housing 1110 adjacent the base 1520 and the lockingmember 1710. The locking member 1710 is configured to engage the firstswitch 1972A such that when the locking member 1710 is removed, as shownin FIG. 1, the first switch 1972A changes states. In this manner,removal of the locking member 1710 can trigger the processor to output apredetermined electronic output.

Similarly, the second switch 1972B is disposed on the housing 1110adjacent the medicament injector 1210. The medicament injector 1210 isconfigured to engage the second switch 1972B such that when themedicament injector 1210 is moved distally within the housing 1110 thesecond switch 1972B changes states. In this manner, the processor can beprompted to output a predetermined electronic output based on theposition of the medicament injector 1210.

The proximity sensor 1974 is disposed on the base 1520 and is configuredto produce an output when the base 1520 engages the body. The proximitysensor can be, for example, a temperature sensor, an optical sensor orthe like. In this manner, the processor can be prompted to output apredetermined electronic output when the base 1520 is positioned againstthe body.

The first visual output device 1958A is disposed on the locking member1710. Similarly, the second visual output device 1958B is disposed onthe outer surface 1111 of the housing 1110. The visual output devices1958A and 1958B are in electronic communication with the processor andare configured to produce an output in response to an electronic signaloutput by the processor. The visual output devices 1958A and 1958B canbe any suitable visual indicia, such as, light-emitting diodes (LEDs),liquid-crystal display (LCD) screens, optical polymers, fiber opticcomponents or the like. In some embodiments, the visual output devices1958A and 1958B can be coupled to the housing 1110 and/or the lockingmember 1710 by a label 1910.

The audio output device 1956 is disposed within the housing 1110 suchthat it can project sound outside of the housing 1110. The audio outputdevice 1956 can be any suitable device for producing sound, such as amicro-speaker a piezo-electric transducer or the like. Such sound outputcan include, for example, an alarm, a series of beeps, recorded speechor the like. The audio output device 1956 is in electronic communicationwith the processor and is configured to produce an output in response toan electronic signal output by the processor.

In use, the user activates the electronic circuit system by pushing thestart button 1970 to activate the processor, thereby causing theprocessor to output a predetermined sequence of electronic outputs. Insome embodiments, the start button 1970 can activate the processor byproviding an input to the processor. In other embodiments, the startbutton 1970 can activate the processor by placing the battery (not shownin FIGS. 1 and 2) in electronic communication with the processor.

In some embodiments, upon activation, the processor can output anelectronic signal to the audio output device 1956 thereby producing afirst electronic output instructing the user in how to use theauto-injector 1002. Such a message can state, for example, “pleaseremove the safety tab.” Additionally, the first visual output device1958A can produce a flashing light to further indicate to the user wherethe locking member 1710 is located. The processor can be configured torepeat the first audible instruction if the locking member 1710 is notremoved within a predetermined time period.

When the user removes the locking member 1710, the first switch 1972Achanges states thereby triggering the processor to output an electronicoutput providing a second instruction to the user. The secondinstruction can be, for example, an audible speech output instructingthe user to “please place the base of the device on the outer portion ofyour thigh.” The first visual output device 1958A can produce a lightedoutput during this audible instruction, thereby visually indicatingwhere the base 1520 is located and/or what portion of the base 1520should be placed on the thigh.

When the user places the base 1520 against the body, the proximitysensor 1974 provides an input to the processor, thereby triggering theprocessor to output an electronic output providing a third instructionto the user. The third instruction can be, for example, an audiblespeech output instructing the user to “push down on the top of thedevice to activate the injector.”

When the injection is completed, the medicament injector 1210 isconfigured to engage the second switch 1972B, thereby triggering theprocessor to output an electronic output providing a fourth instructionto the user. Such a post-use instruction can be, for example, an audiblespeech output instructing the user to seek further medical attention,providing instructions for the safe disposal of the auto-injector 1002or the like.

FIG. 3 is a schematic illustration of the electronic circuit system 1920of the auto-injector 1002. The electronic circuit system 1920 includes aprocessor 1950 operatively coupled to a memory device 1954. The memorydevice 1954 can be configured to store processor-readable code 1955instructing the processor 1950 to perform the functions described above.In some embodiments, the processor-readable code 1955 can be modifiedand/or updated as circumstances dictate. The electronic circuit system1920 includes an input/output device 1952 configured to receiveelectronic inputs from the switches 1972A and 1972B, the proximitysensor 1974 and/or the start button 1970. The input/output device 1952is also configured to provide electronic signals to the various outputdevices, such as the visual output devices 1958A and 1958B and the audiooutput device 1956.

The electronic circuit system 1920 also includes a network interface1953 configured to couple the electronic circuit system 1920 to acommunications network. Such an arrangement can be used, for example, todownload replacement processor-readable code 1955 from a central network(not shown) to the memory device 1954. The network interface 1953 canalso be configured to transmit information from the electronic circuitsystem 1920 to a central network, the user's home computer, the user'scell phone or the like.

FIG. 4 is a schematic illustration of a medical device 2002 according toan embodiment of the invention. The medical device 2002, which can be,for example, a medicament delivery device such as an auto-injector, apen injector, an inhaler, a transdermal delivery system or the like,includes a housing 2110 and a label 2910. The label 2910 is coupled toan outer surface 2111 of the housing 2110. The label 2910 includes afirst surface 2912, a second surface 2914 and an electronic circuitsystem 2920. The first surface 2912 is configured to engage the outersurface 2111 of the housing 2110 to couple the label 2910 to the housing2110. In some embodiments, the first surface 2912 can include anadhesive to fixedly couple the label 2910 to the housing 2110. Thesecond surface 2914 includes a textual indicia 2916. The textual indicia2916 can include, for example, a description of the medicament deliverydevice, a source of the medicament delivery device and/or an instructionassociated with the use of the medicament delivery device. Although thefirst surface 2912 is shown as being opposite the second surface 2914,in other embodiments, the first surface 2912 and the second surface 2914can be adjacent each other and/or co-planar.

The electronic circuit system 2920 is configured to output an electronicsignal. As discussed in more detail herein, the electronic circuitsystem 2920 can include many components, such as, for example, aprocessor, a switch, a visual output device and/or an audio outputdevice. The electronic signal can be, for example, an electronic signalcommunicated to an output device, such as, for example, a visual outputdevice, an audio output device, a haptic output device or the like. Insome embodiments, the electronic signal can be associated with an aspectof the medical device 2002, such as an instruction associated with aninitial use of the medical device 2002. For example, in someembodiments, the electronic circuit system 2920 can output a textmessage to a display screen (not shown) disposed on the medical device2002 instructing the user in the use of the medical device 2002. Inother embodiments, the electronic circuit system 2920 can produce anaudio output, such as recorded speech, instructing the user in the useof the medical device 2002.

Although the electronic circuit system 2920 is shown as being disposedon the second surface 2914 of the label 2910, in other embodiments, theelectronic circuit system can be disposed on the first surface 2912 ofthe label 2910. In yet other embodiments, the electronic circuit system2920 can be disposed between the first surface 2912 and the secondsurface 2914 of the label 2910. In yet other embodiments, the label 2910can include multiple discrete layers coupled together, within whichportions of the electronic circuit system can be disposed.

FIG. 5 is a perspective view of an auto-injector 4002 according to anembodiment of the invention. The auto-injector 4002 is similar to theauto-injectors described in U.S. patent application Ser. No. 11/562,061,entitled “Devices, Systems and Methods for Medicament Delivery,” filedNov. 21, 2006, which is incorporated herein by reference in itsentirety. Accordingly, the mechanical components and operation of theauto-injector 4002 are not described in detail herein.

The auto-injector 4002 includes a housing 4110 having a proximal endportion 4112 and a distal end portion 4114. The distal end portion 4114of the housing 4110 includes a protrusion 4142 to help a user grasp andretain the housing 4110 when using the auto-injector 4002. Said anotherway, the protrusion 4142 is configured to prevent the auto-injector 4002from slipping from the user's grasp during use. A base 4520 is movablycoupled to the distal end portion 4114 of the housing 4110. A needleguard assembly 4810 is removably coupled to the base 4520. Similarly, asafety lock 4710 is removably coupled to the base 4520. To inject amedicament into the body, the distal end portion 4114 of the housing isoriented towards the user such that the base 4520 is in contact with theportion of the body where the injection is to be made. The base 4520 isthen moved towards the proximal end 4112 of the housing 4110 to actuatethe auto-injector 4002. The housing 4110 also includes a transparentstatus window 4118 (see FIG. 5D) to allow a user to determine the statusof the auto-injector 4002 or the medicament contained therein.

FIG. 5A is a perspective view of the auto-injector 4002 showing thehousing 4110 in phantom lines so that the components contained withinthe housing 4110 can be more clearly seen. Similarly, FIG. 5B is a frontview of the auto-injector 4002 showing the housing 4110 in phantomlines. For clarity, the auto-injector 4002 shown in FIGS. 5A and 5B showthe auto-injector 4002 without the needle guard assembly 4810′, thesafety lock 4710′ and the electronic circuit system 4920. Additionally,the auto-injector 4002 shown and described with reference to FIGS. 5A-5Nis presented to described the mechanical components and operation of thedevice. Accordingly, the auto-injector 4002 shown and described withreference to FIGS. 5A-5N includes a needle guard assembly 4810′ thatdoes not include a battery isolation tab 4860 (see e.g. FIG. 12), asafety lock 4710′ that does not include an actuator 4732 (see e.g., FIG.13), and a base 4520′ that does not include an actuator 4538 (see e.g.,FIG. 14).

The auto-injector 4002 includes a medicament injector 4210 and a movablemember 4312 engaged with the medicament injector 4210, each of which aredisposed within the housing 4110. The auto-injector 4002 also includes asystem actuator 4510, a compressed gas container 4412 and a gas releasemechanism 4612. The medicament injector 4210 includes a carrier 4250that is movable within the housing 4110, a medicament container 4262 anda needle 4212. The medicament container 4262 is coupled to the carrier4250. The needle 4212 is disposed within a needle hub portion of thecarrier to allow the needle 4212 to be placed in fluid communicationwith the medicament container 4262 during an injection event.

The movable member 4312 includes a proximal end portion 4316 and adistal end portion 4318. The proximal end portion 4316 includes asurface 4322 that, together with the housing 4110, defines a gas chamber4120. Said another way, the surface 4322 defines a portion of a boundaryof the gas chamber 4120. The proximal end portion 4316 of the movablemember 4312 also includes a seal that engages a portion the innersurface 4122 of the housing 4110 (see FIG. 5D) to fluidically isolatethe gas chamber 4120. The distal end portion 4318 is disposed within themedicament container 4262. In use, the movable member 4312 moves towardsthe distal end portion 4114 of the housing 4110, as indicated by arrow Cin FIG. 5A, in response to a force produced by a pressurized gas on thesurface 4322 of the movable member 4312. As a result, the movable member4312 and the medicament injector 4250 are moved towards the distal endportion 4114 of the housing 4110, thereby exposing the needle 4212 fromthe housing 4110. The movable member 4312 then continues to move withinthe medicament container 4262 to expel a medicament from the medicamentcontainer 4262 through the needle 4212.

The auto-injector 4002 is actuated by the system actuator 4510, which isconfigured to move the compressed gas container 4412 into contact withthe gas release mechanism 4612. The gas release mechanism 4612 puncturesa portion of the compressed gas container 4412 to release thepressurized gas contained therein into the gas chamber 4120 defined bythe housing 4110. The system actuator 4510 includes a rod 4540, a spring4560 and a spring retainer 4570. The rod 4540 has a proximal end portion4542 and a distal end portion 4544. The proximal end portion 4542 of therod 4540 is coupled to the compressed gas container 4412. The distal endportion 4544 of the rod 4540 is coupled to the spring retainer 4570 bytwo projections 4548, which can be moved inwardly towards each other todecouple the rod 4540 from the spring retainer 4570, as discussed below.

The spring 4560 is disposed about the rod 4540 in a compressed statesuch that the spring 4560 is retained by the proximal end portion 4542of the rod 4540 and the spring retainer 4570. In this manner, the rod4540 is spring-loaded such that when the distal end portion 4544 of therod 4540 is decoupled from the spring retainer 4570, the force of thespring 4560 causes the rod 4540, and therefore the compressed gascontainer 4412, to move proximally as indicated by arrow D in FIG. 5Aand into contact with the gas release mechanism 4612.

The base 4520′ defines an opening 4522 configured to receive a portionof the projections 4548 when the base is moved towards the proximal end4112 of the housing 4110, as indicated by arrow E in FIG. 5A. When theprojections 4548 are received within the opening 4522, they are movedtogether causing the distal end portion 4544 of the rod 4540 to bereleased from the spring retainer 4570.

As shown in FIGS. 5A and 5B, the medicament injector 4210 defines alongitudinal axis Lm that is non-coaxial with the longitudinal axis Ledefined by the compressed gas container 4412. Accordingly, themedicament injector 4210, the compressed gas container 4412 and thesystem actuator 4510 are arranged within the housing 4110 such that thehousing has a substantially rectangular shape. Moreover, the non-coaxialrelationship between the medicament injector 4210 and the compressed gascontainer 4412 allows the auto-injector 4002 to be actuated bymanipulating the base 4520′, which is located at the distal end portion4114 of the housing 4110.

Prior to use, the auto-injector 4002 must first be enabled by firstremoving the needle guard 4810′ and then removing the safety lock 4710′.As illustrated by arrow G in FIG. 5E, the needle guard 4810′ is removedby pulling it distally (see also arrow AA in FIG. 12). As described inmore detail below, removal of the needle guard 4810′ also removes theisolation tab 4860 (see FIG. 12), thereby placing the batteries 4962into electrical connection with the electronic circuit system 4910 (notshown in FIGS. 5A-5N, for purposes of clarity). Similarly, asillustrated by arrow H in FIG. 5F, the safety lock 4710′ is removed bypulling it substantially normal to the longitudinal axis Le of thecompressed gas container 4412. Said another way, the safety lock 4710′is removed by moving it in a direction substantially normal to thedirection that the needle guard 4810′ is moved. As described below,removal of the safety lock 4710′ also actuates the electronic circuitsystem 4920 (not shown in FIGS. 5A-5N, for purposes of clarity). Theneedle guard 4810′ and the safety lock 4710′ are cooperatively arrangedto prevent the safety lock 4710′ from being removed before the needleguard 4810′ has been removed. Such an arrangement prevents theauto-injector 4002 from being actuated while the needle guard 4810′ isin place.

As illustrated in FIG. 5G, the needle guard 4810′ includes a sheath 4820and a sheath retainer 4840. The sheath 4820 has a proximal end portion4822 and a distal end portion 4824 and defines an opening 4826configured to receive a portion of the needle 4212 when the needle guard4810′ is in a first (or installed) position. The sheath 4820 furtherdefines a recessed portion 4828 within the opening 4826 that engages acorresponding protrusion 4238 defined by an outer surface 4236 of theneedle hub 4223. In this manner, when the needle guard 4810′ is in itsfirst position, the sheath 4820 is removably coupled to the needle hub4223. In some embodiments, the recessed portion 4828 and the protrusion4238 form a seal that is resistant to microbial penetration.

The sheath retainer 4840 has a proximal portion 4842 and a distalportion 4844. The proximal portion 4842 of the sheath retainer 4840includes a protrusion 4856 that engages a corresponding recess 4526 inthe base 4520′ (see FIG. 5M) to removably couple the sheath retainer4840 to the base 4520. The distal portion 4844 of the sheath retainer4840 defines an opening 4846 through which the distal end portion 4824of the sheath 4820 is disposed. The distal portion 4844 of the sheathretainer 4840 includes a series of retaining tabs 4852 that engage thedistal end portion 4824 of the sheath 4820 to couple the sheath 4820 tothe sheath retainer 4840. In this manner, when the sheath retainer 4840is moved distally away from the base 4520 into a second (or removed)position, as shown in FIG. 5E, the sheath 4820 is removed from theneedle 4412. Moreover, this arrangement allows the sheath 4820 to bedisposed about the needle 4412 independently from when the sheathretainer 4840 is coupled to the sheath 4820. As such, the two-piececonstruction of the needle guard provides flexibility duringmanufacturing. The distal portion 4844 of the sheath retainer 4840 alsoincludes a protrusion 4848 to aid the user when grasping the needleguard 4810.

When the needle guard 4810′ is in its first position, the sheathretainer 4840 is disposed within a recess 4720 defined by one of theextended portions 4716 of the safety lock 4710 (see FIG. 5J). Thisarrangement prevents the safety lock 4710′ from being removed when theneedle guard 4810′ is in its first position, which in turn, prevents theauto-injector 4002 from being actuated when the needle guard 4810′ is inits first position.

The outer surface of the sheath retainer 4840 includes indicia 4850 toinstruct the user in operating the auto-injector 4002. As shown in FIG.5F, the indicia 4850 includes a numeral to indicate the order ofoperation and an arrow to indicate the direction in which the needleguard 4810′ should be moved. In some embodiments, the indicia 4850 caninclude different colors, detailed instructions or any other suitableindicia to instruct the user. In other embodiments, the indicia 4850 canprotrude from the sheath retainer 4840 to aid the user when grasping theneedle guard 4810′.

In some embodiments, the sheath 4820 can be constructed from anysuitable material, such as, for example polypropylene, rubber or anyother elastomer. In some embodiments, the sheath 4820 can be constructedfrom a rigid material to reduce the likelihood of needle sticks duringthe manufacturing process. In other embodiments, the sheath 4820 can beconstructed from a flexible material.

As shown in FIG. 5J, the safety lock 4710′ is a U-shaped member having afirst end 4712 and a second end 4714. The second end 4714 of the safetylock 4710′ includes two extended portions 4716, each of which includesan inwardly facing protrusion 4718. When the safety lock 4710′ is in itsfirst (or locked) position, the extended portions 4716 extend around aportion of the base 4520′ to space the base 4520′ apart from the distalend portion 4114 of the housing 4110. As shown in FIG. 5K, theprotrusions 4718 are configured engage a portion of the base 4520′ toremovably couple the safety lock 4710′ in its first position.Additionally, one of the extended portions 4716 defines a recess 4720that receives the sheath retainer 4840 when the needle guard 4810′ is inits first position.

The first end 4712 of the safety lock 4710′ includes a lockingprotrusion 4722 that extends inwardly. As shown in FIG. 5K, when thesafety lock 4710′ is in its first position, the locking protrusion 4722extends between the projections 4548 of the rod 4540 and obstructs theopening 4522 of the base 4520′. In this manner, when the safety lock4710′ is in its first position, the base 4520′ cannot be movedproximally to allow the projections 4548 to be received within theopening 4522. The arrangement of the locking protrusion 4722 alsoprevents the projections 4548 from being moved inwardly towards eachother. Accordingly, when the safety lock 4710′ is in its first position,the auto-injector 4002 cannot be actuated.

The outer surface 4724 of the first end 4712 of the safety lock 4710′includes a series of ridges 4726 to allow the user to more easily gripthe safety lock 4710′. The outer surface 4724 of the first end 4712 ofthe safety lock 4710′ also includes indicia 4728 to instruct the user inoperating the auto-injector 4002. As shown in FIG. 5J, the indicia 4728includes a numeral to indicate the order of operation and an arrow toindicate the direction in which the safety lock 4710′ should be moved.In some embodiments, the indicia 4728 can include different colors,detailed instructions or any other suitable indicia to instruct theuser. In other embodiments, the indicia 4728 can protrude from thesafety lock 4710′ to aid the user when grasping the safety lock 4710′.

After being enabled, the auto-injector 4002 can then be actuated bymoving the base 4520′ proximally towards the housing 4110, as indicatedby arrow I in FIG. 5L. Additionally, as described below, movement of thebase 4520′ actuates the electronic circuit system 4920 (not shown inFIGS. 5A-5N, for purposes of clarity).

As shown in FIG. 5M, the base 4520′ defines two openings 4536 thatreceive corresponding attachment protrusions 4150 disposed on the distalend portion 4114 of the housing 4110. In this manner, the movementand/or alignment of the base 4520′ relative to the housing 4110 isguided by the attachment protrusions 4150 and the openings 4536. Eachattachment protrusion 4150 is secured within its corresponding opening4536 by a lock washer 4534. The lock washers 4534 each define an opening4535 that receives a portion of the attachment protrusion 4150 (see FIG.5D). The lock washers 4534 are disposed within slots 4533 defined by thebase 4520′ so that the openings 4535 are aligned with the attachmentprotrusions 4150. The openings 4535 are configured to allow the lockwashers 4534 to move proximally relative to the attachment protrusions4150, but to prevent movement of the lock washers 4534 distally relativeto the attachment protrusions 4150. In this manner, when the attachmentprotrusions 4150 are disposed within the openings 4535 of the lockwashers 4534, the base 4520′ becomes fixedly coupled to the housing4110. Moreover, after the base 4520′ is moved proximally relative to thehousing 4110, the lock washers 4534 prevent the base 4520′ fromreturning to its initial position.

The base 4520′ also defines a needle opening 4532, a recess 4526 and tworetraction spring pockets 4531. The needle opening 4532 receives aportion of the needle guard 4810′ when the needle guard is in its firstposition. Additionally, when the auto-injector 4002 is actuated, theneedle 4212 extends through the needle opening 4532. The retractionspring pockets 4531 receive a portion of the retraction springs.

As shown in FIG. 5M, the base 4520′ includes two opposing taperedsurfaces 4524 that define an opening 4522 configured to receive acorresponding tapered surface 4550 of the projections 4548 when the base4520′ is moved proximally towards the housing 4110. When the projections4548 are received within the tapered opening 4522, they are movedtogether as indicated by arrows J in FIG. 5L. The inward movement of theprojections 4548 causes the rod 4540 to become disengaged from thespring retainer 4570, thereby allowing the rod 4540 to be movedproximally along its longitudinal axis as the spring 4560 expands.

Because the rod 4540 is coupled to the compressed gas container 4412,when the rod 4540 is moved from its first (engaged) position to itssecond (actuated) position, the compressed gas container 4412 is movedproximally within the housing 4110 into engagement with the gas releasemechanism 4612. FIG. 5N shows the auto-injector in a secondconfiguration, in which the compressed gas container 4412 is engagedwith the gas release mechanism 4612. When in the second configuration,the compressed gas contained within the compressed gas container 4412 isreleased to actuate the medicament injector 4210.

The pressurized gas produces a force that causes the movable member 4312and the medicament injector 4210 to move distally within the housing4110. The movement of the medicament injector 4210 causes the needle4212 to extend from distal end portion 4114 of the housing 4110 and thebase 4520. This operation can be referred to as the “needle insertion”operation. When the medicament injector 4210 has completed its movement(i.e., the needle insertion operation is complete), the movable member4312 continues to move the medicament container 4262 distally within thecarrier 4250. The continued movement of the medicament container 4262places the needle 4212 in fluid communication with the medicamentcontainer 4262, thereby allowing the medicament to be injected. Theforce from the pressurized gas also causes the movable member 4312 tomove within the medicament container 4262, thereby expelling themedicament through the needle 4212. This operation can be referred to asthe “injection operation.” Upon completion of the injection, thepressurized gas is released from the gas chamber 4120, thereby allowingthe medicament injector 4210 and the movable member 4312 to be movedproximally within the housing. This operation can be referred to as the“retraction operation.”

The auto-injector 4002 includes a label 4910 coupled to an outer surface4111 of the housing 4110. The label 4910 includes an outer layer 4911,an intermediate layer 4980 and an electronic circuit system 4920 (seeFIGS. 7-9). FIG. 6 is a front view of the auto-injector 4002 showing theouter layer 4911 of the label 4910 in phantom lines so that theintermediate layer 4980 and an electronic circuit system 4920 can bemore clearly seen. As shown in FIGS. 7-9, the outer layer 4911, which,in some embodiments, can be constructed from paper, has a first surface4912 and a second surface 4914 opposite the first surface 4912. Multipleindicia 4916 are disposed on the first surface 4912. The indicia 4916include a textual indicia 4916A and two symbolic indicia 4916B. Thetextual indicia 4916B can be written text describing the medicamentdelivery device, indicating a source of the medicament delivery deviceand/or instructing a user in the use of the medicament delivery device.The symbolic indicia 4916B can include, for example, arrows, pointers,trademarks, symbols describing the use of the medicament delivery deviceor the like. The label 4910 is coupled to the outer surface 4111 of thehousing 4110 such that the portion of the first surface 4912 includingthe indicia 4916 is visible.

A portion of the second surface 4914 of the outer layer 4911 can becoupled to the outer surface 4111 of the housing 4110 by any suitablemethod. For example, in some embodiments, the second surface 4914 of theouter layer 4911 includes an adhesive configured to bond the outer layer4911 to the outer surface 4111 of the housing 4110. Other portions ofthe second surface 4914 of the outer layer 4911 are adjacent theintermediate layer 4980 and portions of the electronic circuit system4920. In this manner, the outer layer 4911 of the label 4910 retains theintermediate, or spacer, layer 4980 and the electronic circuit system4920 in a predetermined position against the outer surface 4111 of thehousing 4110.

The outer layer 4911 of the label 4910 includes multiple openings 4917adjacent the audio output device 4956. In this manner, sound wavesproduced by the audio output device 4956 can be transmitted to an areaoutside of the housing 4110. Similarly, the outer layer 4911 of thelabel 4910 includes openings 4918 adjacent the light emitting diodes(LEDs) 4958A and 4958B to allow the user to see the visual output. Insome embodiments, the outer layer 4911 of the label 4910 can include atransparent portion adjacent the LEDs 4958A and 4958B to allow the userto see the visual output.

The electronic circuit system 4920 includes a printed circuit board 4922upon which a microprocessor 4950, two LEDs 4958A and 4958B, two switches4972A and 4972B and various electronic components 4951, such as, forexample, resistors, capacitors and diodes, are mounted. The electroniccircuit system 4920 also includes an audio output device 4956, such as,for example, a micro-speaker, coupled to the outer surface 4111 of thehousing 4110 adjacent the printed circuit board 4922. The printedcircuit board 4922 includes a substrate 4924 upon which a series ofelectrical conductors 4934, such as for example, copper traces, areetched. The substrate 4924 can be constructed from any material havingsuitable electrical properties, mechanical properties and flexibility,such as, for example Mylar®, Kapton® or impregnated paper.

A mask layer (not shown) is disposed over the substrate 4924 toelectrically isolate selected portions of the electrical conductors 4934from adjacent components. The electrical conductors 4934 operativelycouple the above-mentioned circuit components in a predeterminedarrangement. In this manner, the electronic circuit system 4920 can beconfigured to output, via the LEDs 4958A and 4958B and/or the audiooutput device 4956, a predetermined sequence of electronic outputsduring the use of the auto-injector 4002.

Power is supplied to the electronic circuit system 4920 by two batteries4962 connected in series. The batteries can be, for example, three volt,“watch-style” lithium batteries. As shown in FIG. 9, each of thebatteries 4962 has a first surface 4964 and a second surface 4966opposite the first surface. The first surface 4964 can be, for example,an electrically negative terminal. Similarly, the second surface 4966can be an electrically positive terminal. As discussed in more detailherein, the batteries 4962 are positioned such that a first electricalcontact portion 4936 of the printed circuit board 4922 can be placed incontact with the first surface 4964 of the battery 4962 and a secondelectrical contact portion 4938 of the printed circuit board 4922 can beplaced in contact with the second surface 4966 of the battery 4962. Inthis manner, the batteries 4962 can be operatively coupled to theelectronic circuit system 4920.

As shown in FIGS. 7 and 9, a battery isolation tab 4860 is movablydisposed between the first electrical contact portion 4936 of theprinted circuit board 4922 and the first surface 4964 of one of thebatteries 4962. The battery isolation tab 4860 can be constructed fromany electrically isolative material, such as, for example, Mylar®. Asdiscussed in more detail herein, in this manner, the batteries 4962 canbe selectively placed in electronic communication with the electroniccircuit system 4920.

The intermediate, or spacer, layer 4980 is disposed between the outerlayer 4911 and the electronic circuit system 4920. The intermediatelayer 4980 includes openings (not shown) within which various componentsof the electronic circuit system, such as, for example, the batteries4962 are disposed. The intermediate layer 4980 is sized to maintain apredetermined spacing between the various components included in thelabel 4910. The intermediate layer can be constructed from any suitablematerial, such as, for example, flexible foam having an adhesivesurface, polycarbonate or the like.

FIG. 10 is a front view of the electronic circuit system 4920 showingthe arrangement of the various components (i.e., the microprocessor4950, LEDs 4958A and 4958B, switches 4972A and 4972B, audio outputdevice 4956 or the like). FIG. 11 is a schematic illustration of theelectronic circuit system 4920.

The operation of the auto-injector 4002 and the electronic circuitsystem 4920 is now discussed with reference to FIGS. 12-14. Theactuation of the electronic circuit system 4920 includes severaloperations that are incorporated into the standard procedures for usingthe auto-injector 4002. In this manner, the user can actuate theelectronic circuit system 4920 without completing any additionaloperations.

Prior to use, the auto-injector 4002 is first enabled by removing theneedle guard 4810 and the safety lock 4710 (see FIGS. 12 and 13). Asillustrated by arrow AA in FIG. 12, the needle guard 4810 is removed bymoving it distally. The needle guard 4810 includes a sheath retainer4840 and a sheath 4820. The sheath 4820 is configured to receive aportion of the needle (not shown) when the needle guard 4810 is in afirst (or installed) position. The sheath retainer 4840 is coupled tothe sheath 4820 such that when the sheath retainer 4840 is moveddistally away from the base 4520 into a second (or removed) position,the sheath 4820 is removed from the needle.

The sheath retainer 4840 includes an actuator 4864 that is received byan opening 4862 in the isolation tab 4860. Accordingly, when the sheathretainer 4840 is moved distally away from the base 4520, the isolationtab 4860 is removed from the area between the first electrical contactportion 4936 of the printed circuit board 4922 and the first surface4964 of one of the batteries 4962. In this manner, the batteries 4962can be operatively coupled to the electronic circuit system 4920 whenthe needle guard 4810 is removed, thereby actuating the electroniccircuit system 4920.

When actuated, the electronic circuit system 4920 can output one or morepredetermined electronic outputs. For example, in some embodiments, theprocessor 4950 can output an electronic signal associated with recordedspeech to the audible output device 4956. Such an electronic signal canbe, for example, associated with a .WAV file that contains a recordedinstruction instructing the user in the operation of the auto-injector4002. Such an instruction can state, for example, “remove the bluesafety tab near the base of the auto-injector.” The processor cansimultaneously output an electronic signal to the first LED 4958A,thereby causing the first LED 4958A, which is located near the safetylock 4710, to flash a particular color. In this manner, the electroniccircuit system 4920 can provide both audible and visual instructions toassist the user in the initial operation of the auto-injector 4002.

In other embodiments, the electronic circuit system 4920 can output anelectronic output associated with a description and/or status of theauto-injector 4002 and/or the medicament contained therein. For example,in some embodiments, electronic circuit system 4920 can output anaudible message indicating the type of medicament contained in theauto-injector, the expiration date of the medicament, the dosage of themedicament or the like.

As illustrated by arrow BB in FIG. 13, the safety lock 4710 is removedby moving it substantially normal to the longitudinal axis of thehousing 4110. The safety lock 4710 has a first end 4712 and a second end4714. When the safety lock 4710 is in its first (or locked) position,the second end 4714 extends around a portion of the base 4520 to spacethe base 4520 apart from the distal end portion 4114 of the housing4110. Additionally, the first end 4714 includes a locking protrusion(not shown) that obstructs portions of the system actuator (not shown)further preventing the base 4520 from being moved proximally towards thehousing 4110. Accordingly, when the safety lock 4710 is in its firstposition, the auto-injector 4002 cannot be actuated.

In some embodiments, the safety lock 4710 includes an actuator 4732 thatactuates the electronic circuit 4920 to trigger a predetermined outputor sequence of outputs when the safety lock 4710 is moved from the firstposition to a second (or unlocked) position, as shown in FIG. 13. Moreparticularly, as shown in FIGS. 10, 15 and 16, the actuator 4732includes a protrusion 4730 that is received within a first opening 4928Adefined by an actuation portion 4926 of the substrate 4924 when thesafety lock 4710 is in the first position. The boundary 4929 of thefirst opening 4928A has a discontinuous shape, such as, for example, ateardrop shape, that includes a stress concentration riser 4930. Thediscontinuity and/or the stress concentration riser 4930 of the boundary4929 can be of any suitable shape to cause the substrate 4924 to deformin a predetermined direction when the protrusion 4730 is moved relativeto the first opening 4928A.

As shown in FIGS. 15 and 16, the first opening 4928A is defined adjacentan electrical conductor 4934 that, as discussed above, electronicallycouples the components included in the electronic circuit system 4920.The electrical conductor 4934 includes a first switch 4972A, which canbe, for example a frangible portion of the electrical conductor 4934. Inuse, when the safety lock 4710 is moved from the first position to thesecond position, the actuator 4732 moves in a direction substantiallyparallel to a plane defined by a surface of the actuation portion 4926of the substrate 4924. The movement of the actuator 4732 causes theprotrusion 4730 to move within the first opening 4928A, as indicated bythe arrow DD in FIG. 16. The movement of the protrusion 4730 tears theactuation portion 4926 of the substrate 4924, thereby separating theportion of the electrical conductor 4934 including the first switch4972A. Said another way, when the safety lock 4710 is moved to thesecond position, the actuator 4732 moves irreversibly the first switch4972A from a first state (e.g., a state of electrical continuity) to asecond state (e.g., a state of electrical discontinuity).

When the actuator 4732 actuates the electronic circuit system 4920 asdescribed above, the electronic circuit system 4920 can output one ormore predetermined electronic outputs. For example, in some embodiments,the processor 4950 can output an electronic signal associated withrecorded speech to the audible output device 4956. Such an electronicsignal can be, for example, associated with a recorded message notifyingthe user of the status of the auto-injector 4002. Such a status messagecan state, for example, “The auto-injector is now enabled.” Theprocessor can also simultaneously output an electronic signal to thefirst LED 4958A, thereby causing the first LED 4958A to stop flashing,change color or the like.

In some embodiments, the electronic circuit system 4920 can beconfigured to output the status message for a predetermined time period,such as, for example, five seconds. After the predetermined time periodhas elapsed, the electronic circuit system 4920 can output an audiblemessage further instructing the user in the operation of theauto-injector 4002. Such an instruction can state, for example, “Placethe base of the auto-injector against the patient's thigh. To completethe injection, press the base firmly against the patient's thigh.” Insome embodiments, the processor can simultaneously output an electronicsignal to the second LED 4958B, thereby causing the second LED 4958B,which is located near the base 4520, to flash a particular color. Inthis manner, the electronic circuit system 4920 can provide both audibleand visual instructions to assist the user in the placement andactuation of the auto-injector 4002. In some embodiments, the electroniccircuit system 4920 can be configured to repeat the instructions after apredetermined time period has elapsed.

After the auto-injector 4002 is enabled and placed against the body ofthe patient, the auto-injector 4002 is actuated by moving the base 4520proximally towards the housing 4110, as illustrated by arrow CC in FIG.14. The base 4520 includes an actuator 4538 that actuates the electroniccircuit 4920 to trigger a predetermined output or sequence of outputswhen the base 4520 is moved from a first position to a second position,as shown in FIG. 13. The actuator 4538 includes a protrusion 4539 thatis received within a second opening 4928B (see FIG. 10) defined by thesubstrate 4924 when the base 4520 is in the first position. Theconfiguration and operation of the protrusion 4539, the second opening4928B and the second switch 4972B are similar to the configuration andoperation of the protrusion 4730, the first opening 4928A and the firstswitch 4972A, and are therefore not described in detail.

When the actuator 4538 actuates the electronic circuit system 4920, theelectronic circuit system 4920 can output one or more predeterminedelectronic outputs. For example, in some embodiments, the processor 4950can output an electronic signal associated with recorded speech to theaudible output device 4956. Such an electronic signal can be, forexample, associated with a recorded message notifying the user that theinjection is complete, instructing the user on post-injection disposaland safety procedures, instructing the user on post-injection medicaltreatment or the like. Such a status message can state, for example,“The injection is now complete. Please seek further medical attentionfrom a doctor.” The processor can also simultaneously output anelectronic signal to the first LED 4958A, thereby causing the first LED4958A to stop flashing, change color or the like, to provide a visualindication that the injection is complete.

As described above, the batteries 4962 are positioned such that thefirst electrical contact portions 4936 of the printed circuit board 4922can be placed in contact with the first surface 4964 of each battery4962 and the second electrical contact portion 4938 of the printedcircuit board 4922 can be placed in contact with the second surface 4966of each battery 4962. As shown in FIGS. 10 and 17, the first electricalcontact portions 4936 each include a pair of electrical contacts 4937that are operatively coupled to the electronic circuit system 4920.Similarly, the second electrical contact portion 4938 includes a pair ofelectrical contacts 4939 that is operatively coupled to the electroniccircuit system 4920.

The first electrical contact portions 4936 and the second electricalcontact portion 4938 are monolithically constructed from the printedcircuit board 4922. FIGS. 17-20 are perspective views showing theprinted circuit board 4922 in various stages of manufacture. FIG. 21 isa flow chart illustrating a method 5000 for manufacturing a flexibleprinted circuit board according to an embodiment of the invention. Theillustrated method includes disposing a copper layer on the top surface4925 of the flexible substrate 4924 and etching the desired series ofelectrical conductors (not shown in FIGS. 17-20) at 5002. A mask layer(not shown) is disposed on portions of the top layer 4925 of thesubstrate 4924 to electrically isolate selected portions of theelectrical conductors from adjacent components at 5004. During thisoperation, the electrical contacts 4937, 4939 are constructed.

The printed circuit board 4922 is then populated with themicroprocessor, switches, output devices and/or other electroniccomponents to form the electronic circuit system 4920 at 5006. Forclarity, the circuit components are not shown in FIGS. 17-20. After theprinted circuit board 4922 is populated, the portion of the flexiblesubstrate 4924 forming the second electrical contact portion 4938 isseparated from the remainder of the substrate 4924 at 5008. As shown inFIG. 17, during this operation, a portion 4923 of the boundary betweenthe second electrical contact portion 4938 and the remainder of thesubstrate 4924 is left intact.

As shown by the arrow EE in FIG. 18, the second electrical contactportion 4938 is then moved upwardly away from the remainder of thesubstrate 4924 at 5010. In this manner, the second electrical contactportion 4938 is spaced apart from the first electrical contact portions4936. As shown by the arrow FF in FIG. 19, the portion of the secondelectrical contact portion 4938 containing the electrical contacts 4939is then folded so that the electrical contacts 4939 on the secondelectrical contact portion 4938 are facing the electrical contacts 4937on the first electrical contact portions 4936, at 5012. In this manner,opposing electrical contacts 4937, 4939 are constructed on the printedcircuit board 4922 without disposing electrical conductors on and/oretching multiple surfaces of the printed circuit board 4922.

The batteries 4962 are then disposed between the first electricalcontact portions 4936 and the second electrical contact portion 4938 at5014. Although not shown in FIG. 19, in some embodiments, a batteryisolation tab of the type discussed above can be disposed between one ofthe batteries and the printed circuit board 4922. Once the batteries4962 are in place, the top layer 4911 of the label 4910 is disposedabout the printed circuit board 4922 (see FIG. 20) to maintain theposition of the batteries 4962 within the printed circuit board 4922, at5016. The label assembly 4910 is then coupled to the outer surface ofthe housing (not shown) at 5018. The label 4910 is coupled to thehousing with sufficient tension and/or stretch to maintain theelectrical contacts 4937 in electrical communication with the firstsurface 4964 of each battery 4962 and to maintain the electricalcontacts 4939 in electrical communication with the second surface 4966of each battery 4962. In this manner, the batteries 4962 can be held inplace in a printed circuit board 4922 devoid of springs, clips or otherrigid members.

As described above, the audio output device 4956, can include, forexample, a micro-speaker. In some embodiments, for example, the audiooutput device 4956 can include an RS-1511A micro-speaker manufactured byRegal Electronics, Inc.

Similarly, the microprocessor 4950 can be a commercially-availableprocessing device dedicated to performing one or more specific tasks.For example, in some embodiments, the microprocessor 4950 can be acommercially-available microprocessor, such as the Sonix SNC 12060 voicesynthesizer. Alternatively, the microprocessor 4950 can be anapplication-specific integrated circuit (ASIC) or a combination ofASICs, which are designed to perform one or more specific functions. Inyet other embodiments, the microprocessor 4950 can be an analog ordigital circuit, or a combination of multiple circuits.

The microprocessor 4950 can include a memory device (not shown)configured to receive and store information, such as a series ofinstructions, processor-readable code, a digitized signal, or the like.The memory device can include one or more types of memory. For example,the memory device can include a read only memory (ROM) component and arandom access memory (RAM) component. The memory device can also includeother types of memory suitable for storing data in a form retrievable bythe microprocessor 4950, for example, electronically-programmable readonly memory (EPROM), erasable electronically-programmable read onlymemory (EEPROM), or flash memory.

FIG. 22 is a flow chart illustrating a method 5040 for manufacturing amedical device according to an embodiment of the invention. The medicaldevice can be any medicament delivery device of the type discussedabove, such as, for example, an auto-injector, a pen injector, aninhaler, or a transdermal delivery device. The medical device can alsobe a medicament container, such as, for example, a pill bottle, ablister pack an intravenous solution bag or the like. The illustratedmethod includes assembling the medical device, 5042. After the medicaldevice is assembled, an electronic circuit system is placed on an outersurface of the medicament delivery device, 5044. The electronic circuitsystem can be any electronic circuit system of the type shown anddescribed above. In some embodiments, the electronic circuit system isplaced on the outer surface of the medical device in a predeterminedorientation. For example, in some embodiments, the electronic circuitsystem can include openings, such as openings 4928 that are aligned withmating portions of the medical device, such as, for example, protrusions4730, 4538. In other embodiments, however, the electronic circuit systemcan be placed on the outer surface of the medical device in anyorientation.

After the electronic circuit system is placed on an outer surface of themedical device, a label is coupled to the medical device, 5046. Thelabel, which can be, for example, a label containing a textual indicia,is coupled to the medical device such that a portion of the label isdisposed about the electronic circuit system. In this manner, thecoupling of the label to the medical device also serves to maintain theelectronic circuit system in its position against the outer surface ofthe medicament delivery device.

FIG. 23 is a flow chart illustrating a method 5060 for manufacturing amedical device according to an embodiment of the invention. The medicaldevice can be any medicament delivery device of the type discussedabove, such as, for example, an auto-injector, a pen injector, aninhaler, or a transdermal delivery device. The medical device can alsobe a medicament container, such as, for example, a pill bottle, ablister pack, an intravenous (IV) bag or the like. The illustratedmethod includes assembling the medical device, 5062. The medical deviceis then sterilized using any suitable sterilization process, 5064. Insome embodiments, for example, such as those embodiments in which themedicament is epinephrine, the medical device can be sterilized byexposure to ethylene oxide (EtO) gas. In other embodiments, the medicaldevice can be sterilized by exposure to gamma radiation. In yet otherembodiments, the medical device can be sterilized by exposure to heat,such as for example, by placing the medicament delivery device into anautoclave.

In parallel with the manufacture of the medical device, the illustratedmethod includes constructing an electronic circuit system of the typeshown and described above, 5066. The electronic circuit system is thencoupled to a label, 5068, to form a label assembly. Because the circuitconstruction is done apart from the manufacture of the medicamentdelivery device, it is not subjected the sterilization process, which,in some instances, may damage the circuit components.

The illustrated method then includes placing the label assembly on theouter surface of the medical device, 5070. The label assembly is thencoupled to the outer surface of the medical device, 5072. In someembodiments, the label assembly can be coupled to the medicamentdelivery device by an adhesive, an elastic fastener, a shrink wrap orany other suitable method.

While various embodiments of the invention are described herein, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although the first surface 4912 of the top layer 4911 ofthe label 4910 is shown and described as being opposite the secondsurface 4914 of the top layer 4911 of the label 4910, in otherembodiments, the first surface 4912 and the second surface 4914 can beadjacent each other and/or co-planar. Similarly, although the top layer4911 of the label 4910 is shown and described as covering substantiallyall of the housing 4110, in some embodiments, the top layer 4911 of thelabel 4910 can cover only a portion of the housing.

Although the label 4910 is shown and described as including a top layer4911, an intermediate layer 4980 and a printed circuit board 4922, insome embodiments, the layers comprising the label 4910 can be arrangedin any suitable order. For example, in some embodiments, a multi-layeredlabel can include a printed circuit board as an intermediate layer. Inother embodiments, a multi-layered label can include a printed circuitboard as the outer layer. Moreover, in yet other embodiments, the labelneed not include multiple layers. For example, in some embodiments, alabel can include a single layer that includes an electronic circuitsystem and textual indicia.

Although the indicia 4916 are shown and described as being visible(e.g., textual indicia and/or symbolic indicia), in some embodiments, alabel can include indicia that are haptic. For example, in someembodiments a label can include Braille. In other embodiments, a labelcan include indicia having a distinct feel, such as for example, aparticularly rough or smooth surface.

Although the electronic circuit system 4920 is shown and described asincluding a printed circuit board 4922 having a flexible substrate 4924,in other embodiments, an electronic circuit system can include a rigidprinted circuit board. In yet other embodiments, an electronic circuitsystem can include a printed circuit board having a substrate having atleast a rigid portion.

Moreover, in some embodiments, an electronic circuit system need notinclude a printed circuit board. For example, in some embodiments, anelectronic circuit system can include electronic components operativelycoupled by any suitable method other than by a printed circuit board.

Similarly, although the components included in the electronic circuitsystem 4920 (e.g., the microprocessor 4950, the LEDs 4958A and 4958B orthe like) are shown and described as being operatively coupled byelectrical conductors 4934, in other embodiments, the components can beoperatively coupled without being physically connected. For example, insome embodiments, at least a portion of the components included in anelectronic circuit system can be inductively coupled. In otherembodiments, at least a portion of the components included in anelectronic circuit system can be evanescently coupled.

Although the switches 4972A and 4972B are shown and described as being“tear-through” switches that are monolithically formed from theelectrical conductors 4934, in other embodiments, a switch can be formedseparately from the electrical conductors 4934. For example, in someembodiments, an electrical circuit system can include a series of firstelectrical conductors having a first set of characteristics (e.g., thewidth, height, material from which the conductor is fabricated or thelike) and a switch constructed from a second electrical conductor havinga second set of characteristics different than the first set ofcharacteristics. In other embodiments, a switch can be a separatecomponent, such as, for example, a microswitch, that is mounted to theprinted circuit board. In yet other embodiments, an electrical circuitsystem can include a “pop-out” switch that includes a biasing member tobias the switch in a predetermined state. In yet other embodiments, anelectrical circuit system can include a switch that is disposed at alocation other than on a printed circuit board.

Similarly, although the switches 4972A and 4972B are shown and describedas being irreversibly movable from a first state to a second state, inother embodiments, a switch can be reversibly movable between a firststate and a second state. Moreover, in yet other embodiments, a switchcan have more than two distinct states.

Although the actuators 4732, 4539 are shown and described as beingconfigured to move in a direction substantially parallel to the surfaceof the substrate 4924, in other embodiments, an actuator can beconfigured to actuate an electronic circuit system by moving in anydirection. For example, in some embodiments a circuit actuator can bemoved in a direction substantially normal to a portion of an electroniccircuit system.

Similarly, although the actuators 4732, 4539 are shown and described asactuating the switches 4972A and 4972B by tearing and/or deforming aportion of the substrate 4924, in other embodiments, a switch can bemoved from a first state to a second state without deforming thesubstrate. For example, in some embodiments, an electronic circuitsystem can include a printed circuit board having a substrate and afrangible switch tab disposed on the substrate. An electrical conductorand/or a switch can be disposed on the frangible switch tab, such thatwhen the switch tab is removed from the substrate the switch is movedfrom a first state to a second state. In this manner, the switch can beactuated without tearing and/or deforming a portion of the substrate.

Although the actuators 4732, 4539 are shown and described as beingincluded on the safety lock 4710 and the base 4520, respectively, inother embodiments, the actuators can be included on any component of amedicament delivery device. For example, in some embodiments, anauto-injector can include a start button having an actuator configuredto actuate an electronic circuit system. In other embodiments, anauto-injector can include a movable member configured to move amedicament container and/or a needle within a housing of theauto-injector, the movable member including an actuator configured toactuate an electronic circuit system.

Although the safety lock 4710 is shown and described as being removedfrom the housing 4110 of the auto-injector 4002 when in its secondposition, in other embodiments, a safety lock can remain coupled to thehousing of an auto-injector when in its second position. For example, insome embodiments, a safety lock can be moved from its first position toits second position by rotating a portion of the safety lock.

Certain components of the auto-injector 4002 are shown and described asbeing coupled together via protrusions and mating openings. Theprotrusions and/or openings can be disposed on any of the components tobe coupled together and need not be limited to only a certain component.For example, the safety lock 4710 is shown and described as including anactuator 4732 having a protrusion 4730 configured to be received withinan opening 4928A defined by the substrate 4924. In some embodiments,however, the protrusions can be disposed on the substrate 4924 and themating openings can be defined by the actuator 4732. In otherembodiments, such components can be coupled together in any suitableway, which need not include protrusions and mating openings. Forexample, in some embodiments, an actuator can be operatively coupled toan actuation portion of a substrate via mating shoulders, clips,adhesive or the like.

Similarly, although certain components of the auto-injector 4002 areshown and described as being constructed from multiple separatecomponents, in some embodiments, such components can be monolithicallyconstructed. For example, the needle guard 4810 and the batteryisolation tab 4860 are shown and described as being constructedseparately and then coupled together. In other embodiments, a needleguard and a battery isolation tab can be constructed monolithically.

Although the electronic circuit systems are shown and described hereinas including a proximity sensor, in other embodiments, an electroniccircuit system can include any suitable sensor for providing feedback tothe electronic circuit system. For example, in some embodiments, theelectronic circuit system can include a pressure sensor configured tosense the internal gas pressure within a gas-powered auto-injector. Inthis manner, the electronic circuit system can output an instructionand/or a status message when the internal gas pressure crosses apredetermined threshold. For example, in some embodiments, when theinternal gas pressure rapidly increases, the electronic circuit systemcan output a message, such as, for example, “Internal gas chamber hasbeen successfully punctured—injection is in process.”

Similarly, in some embodiments, the electronic circuit system caninclude a temperature sensor configured to sense the temperature of themedicament contained within the medicament delivery device. In thismanner, the electronic circuit system can output an instruction and/or astatus message when the medicament is too cold for effective delivery.For example, in some embodiments, when the medicament is too cold foreffective delivery (this may occur, for example, if the medicamentdelivery device has been left outside overnight), the electronic circuitsystem can output a message, such as, for example, “Medicament is toocold—please briskly rub the auto-injector between your hands.”

Although the batteries 4962 are shown and described as having a firstsurface 4964 (an electrically negative terminal) and a second surface4966 (an electrically positive terminal) opposite the first surface, inother embodiments the batteries can include a first surface and a secondsurface that are adjacent each other and/or co-planar. In otherembodiments, an electronic circuit system can be powered by a batteryhaving any shape and/or any number of surfaces. In yet otherembodiments, an electronic circuit system can be powered by any suitableenergy storage device, such as, for example, a capacitor, solar cell,spring actuated generator, or the like.

Although the medicament delivery devices have been shown and describedabove as being primarily single-use medical injectors, in someembodiments a medicament delivery device can include any suitable devicefor delivering one or more doses of a medicament into a patient's body.For example, in some embodiments, a medicament delivery device can be apen injector containing multiple doses of a chronic-care medicament,such as, for example, insulin. In such embodiments, an electroniccircuit system can output instructions associated with not only aninitial use of the medicament delivery device, but also associated withrepeated uses, dosage monitoring or the like. In other embodiments, amedicament delivery device can include a transdermal medicament deliverydevice, an inhaler or a nasal medicament delivery device.

FIGS. 24 and 25 show an inhaler 6002 according to an embodiment of theinvention. The inhaler 6002 includes a housing 6110 and a medicamentcontainer 6262 movably disposed within the housing 6110. The medicamentcontainer 6262 includes a metering mechanism (not shown in FIGS. 24 and25) configured to discharge a predetermined volume of medicament whenthe inhaler 6002 is actuated.

The housing 6110 has a proximal end portion 6112 and a distal endportion 6114. A label 6910, which includes at least a portion of anelectronic circuit system 6920, is disposed on an outer surface 6111 ofthe housing 6110. As described above, a portion of the label 6910 caninclude a textual indicia 6916. Similar to the electronic circuitsystems shown and described above, the electronic circuit system 6920 isconfigured to output at least one electronic signal associated with theuser of the inhaler 6002. The electronic circuit system 6920 includes amicroprocessor (not shown), a microspeaker 6956 and an LED 6958. Theelectronic circuit system 6920 also includes a motion sensor 6976, thefunction of which is discussed in more detail below.

The distal end portion 6114 of the housing 6110 includes a mouthpiece6212 about which a protective cap 6710 is disposed. Prior to use, theinhaler 6002 is first enabled by removing the protective cap 6710, asshown by the arrow GG in FIG. 25. The protective cap 6710 includes anactuator 6732 that actuates the electronic circuit system 6920 totrigger a predetermined output or sequence of outputs when theprotective cap 6710 is removed. In some embodiments, the actuator 6732can include a protrusion that is received by an actuation portion of theelectronic circuit system 6920, in a similar manner as described above.In other embodiments, the actuator 6732 can be configured to engage amicroswitch that can be repeatedly moved between a first state and asecond state.

When actuated, the electronic circuit system 6920 can output one or morepredetermined electronic outputs. For example, in some embodiments, theelectronic circuit system 6920 can output an audible message via themicrospeaker 6956 instructing the user to “vigorously shake the inhalerfor five seconds.” The processor can simultaneously enable the motionsensor 6976.

Upon receiving a predetermined input from the motion sensor 6976, whichcan be any sensor suitable for detecting the rapid motion of the inhaler6002, the processor can then send an electronic signal to produce asecond audible message. Such a message can state, for example, “theinhaler is now sufficiently shaken and is ready for use.” In someembodiments, the electronic circuit system 6920 can also output aninstruction associated with the correct placement of the inhaler 6002.For example, the electronic circuit system 6920 can output an audiblemessage stating “please place the mouthpiece in your mouth and firmlypress down on the medicament container.” The electronic circuit system6920 can also simultaneously output a signal to the LED 6958 to providea visual indication of where the mouthpiece 6212 is located.

After the inhaler 6002 is enabled and placed within the mouth of thepatient, the inhaler 6002 is actuated by moving the medicament container6262 distally within housing 6110, as illustrated by arrow HH in FIG.25. In some embodiments, the medicament container 6262 can include anactuator (not shown) that actuates the electronic circuit 6920, in amanner similar to those described above, to trigger a predeterminedoutput or sequence of outputs. For example, in some embodiments, theprocessor can output an electronic signal associated with recordedspeech to the microspeaker 6956. Such an electronic signal can be, forexample, associated with a recorded message notifying the user that theinjection is complete, instructing the user on post-injectionprocedures, instructing the user on post-injection medical treatment orthe like. Such a status message can state, for example, “The injectionis now complete.”

In other embodiments, a medicament delivery device can include atransdermal medicament delivery device, such as for example, amedicament patch. In such embodiments, an electronic circuit system canbe configured, for example, to output instructions associated with theenablement, placement and/or removal of the transdermal medicamentdelivery device. For example, in some embodiments, the electroniccircuit system can be actuated by removing a protective barrier thatseals the portion of the device that contacts the skin.

Although the medical devices are shown and described above as beingmedicament delivery devices, such as, for example, medical injectors,inhalers or the like, in other embodiments, a medical device can includea medicament container, such as, for example, a pill bottle, a blisterpack or the like. In yet other embodiments, a medical device can includea container configured to contain one or more medicament deliverydevices. For example, FIGS. 26-28 are schematic illustrations of amedical device 100 according to an embodiment of the invention in afirst configuration, a second configuration and a third configuration,respectively. The medical device 100 includes a container 110 includingan electronic circuit system 130 and defining an internal region 112.The internal region 112 is configured to contain one or more medicamentdelivery devices. Disposed within the internal region 112 are at least afirst medicament delivery device 150 and a second medicament deliverydevice 152. The first medicament delivery device 150 and/or the secondmedicament delivery device 152 can be any suitable medicament deliverydevice, such as, for example, an auto-injector, a pen injector, aninhaler or the like.

As shown in FIG. 27, the electronic circuit system 130 is configured tooutput a first electronic output OP1 when the first medicament deliverydevice 150 is removed from the internal region 112 of the container 110,as indicated by the arrow A. As discussed in more detail herein, thefirst electronic output OP1 can be associated with an identification ofthe first medicament delivery device 150, an identification of aphysical condition and/or an instruction for using the first medicamentdelivery device 150. Moreover, the first electronic output OP1 caninclude a visual output, an audible output and/or a haptic output. Forexample, in some embodiments, the first electronic output OP1 can beassociated with an audible message instructing a user in the use of thefirst medicament delivery device 150. Such an audible message can state,for example, “You have removed an auto-injector containing Epinephrine.To actuate the auto-injector, first remove the red safety tab located atthe end of the auto-injector.” In other embodiments, for example, thefirst electronic output OP1 can be associated with a visual text messageinstructing to perform a series of tests on and/or observe the symptomsexhibited by a patient to determine whether the patient is sufferingfrom a certain physical condition (e.g., anaphylactic shock).

Similarly, as shown in FIG. 28, the electronic circuit system 130 isconfigured to output a second electronic output OP2 when the secondmedicament delivery device 152 is removed from the internal region 112of the container 110, as indicated by the arrow B. The second electronicoutput OP2, which is different than the first electronic output OP1, caninclude a visual output, an audible output and/or a haptic output.Moreover, as with the first electronic output OP1, the second electronicoutput OP2 can be associated with at least one of an identification ofthe second medicament delivery device 152, an identification of aphysical condition and/or an instruction for using the second medicamentdelivery device 152. In this manner, the electronic circuit system 130can provide the user with information about the particular medicamentdelivery device that has been removed from the container 110.

Although the second electronic output OP2 is described as beingdifferent than the first electronic output OP1, in some embodiments, thesecond electronic output OP2 can be the same as the first electronicoutput OP1. In some embodiments, for example, the second electronicoutput OP2 can include the same information as previously output via thefirst electronic output OP1 along with additional information. In thismanner, the second electronic output OP2 can confirm the instructionsand/or information provided by the first electronic output OP1.

The container 110 can be any container suitable for containing aplurality of medicament delivery devices. For example, in someembodiments, the container 110 can be a box-like structure that includesa lid or cover that can be repeatedly opened and closed to selectivelyexpose the internal region 112 of the container 110 to an area outsidethe container 110. In other embodiments, the container 110 can include afrangible portion that can be irreversibly moved to expose the internalregion 112 of the container 110 to allow access to the first medicamentdelivery device 150 and/or the second medicament delivery device 152.

The container 110 can be either portable or permanently installed at aparticular location. For example, in some embodiments, the container 110can be configured to be moved by the user. For example, in suchembodiments, a user may carry the container 110 to events, such aspicnics, field trips, children's camps or the like, where the likelihoodof use increases. In other embodiments, the container 110 can beremovably coupled to a mounting area within a building, such as arestaurant, airport and/or shopping mall. In this manner, when a userrecognizes an emergency situation, the user can locate the container 110and move it to the area in which the emergency situation is occurring.In yet other embodiments, the container 110 can be permanently coupledto a wall of a building.

The container 110 can be constructed from any suitable material, suchas, for example, plastic, metal alloys, insulative foam, fabric or anycombination thereof. In some embodiments, for example, the container 110can include a hard, plastic outer casing and an insulative,shock-absorbing inner liner. In some embodiments, the container 110 canbe constructed from a waterproof material and/or can be configured tofloat. In some embodiments, the container 110 can be constructed from amaterial configured to prevent light from reaching the interior region112 of the container. In this manner, the container can prevent themedicaments contained therein from being exposed to light that canimpact the chemical structure and/or stability of the medicament.

Although the container 110 is shown and described above as containing afirst medicament delivery device 150 and a second medicament deliverydevice 152 having similar sizes and/or shapes, in some embodiments, acontainer can be configured to include medicament delivery devices ofdifferent sizes and/or shapes. For example, in some embodiments, acontainer can be configured to include a medical injector having a long,narrow shape and an inhaler having a wider shape.

FIGS. 29-31 are schematic illustrations of a medical device 200according to one such embodiment of the invention in a firstconfiguration, a second configuration and a third configuration,respectively. The medical device 200 includes a container 210 includingan electronic circuit system 230 and defining an internal region 212.The internal region 212 includes a first retainer 214 and a secondretainer 216. The first retainer 214 retains a first medicament deliverydevice 250 within the internal region 212 of the container. Similarly,the second retainer 216 retains a second medicament delivery device 252within the internal region 212 of the container.

The electronic circuit system 230 includes a first switch 236 associatedwith the first retainer 214 and a second switch 237 associated with thesecond retainer 216. The first switch 236 is configured move between afirst state (e.g., closed) and a second state (e.g., opened) when thefirst medicament delivery device 250 is removed from the first retainer214. Similarly, the second switch 237 is configured move between a firststate and a second state when the second medicament delivery device 252is removed from the second retainer 216. In this manner, the electroniccircuit system 230 can output electronic outputs based on the state ofthe first switch 236 and/or the second switch 237.

More particularly, as shown in FIG. 30, the electronic circuit system230 is configured to output a first electronic output OP3, of the typedescribed above, when the first medicament delivery device 250 isremoved from the first retainer 214, as indicated by the arrow C.Similarly, as shown in FIG. 31, the electronic circuit system 230 isconfigured to output a second electronic output OP4, of the typedescribed above, when the second medicament delivery device 252 isremoved from the second retainer 216, as indicated by the arrow D. Saidanother way, the electronic circuit system 230 is configured to outputthe first electronic output OP3 in response to the first switch 236moving between its first state and its second state. Similarly, theelectronic circuit system 230 is configured to output the secondelectronic output OP4 in response to the second switch 237 movingbetween its first state and its second state.

The first retainer 214 can be any structure that cooperates with thefirst medicament delivery device 250 to retain the first medicamentdelivery device 250 within the internal region 212 of the container 210.Similarly, the second retainer 216 can be any structure that cooperateswith the second medicament delivery device 252 to retain the secondmedicament delivery device 252 within the internal region 212 of thecontainer 210. In some embodiments, for example, the first retainer 214can be a recessed portion (not shown in FIGS. 29-31) of the internalregion 212 having a shape to receive at least a portion of the firstmedicament delivery device 250. Such a recess can include, for example,an edge, a contour or a ridge that forms an interference fit with aportion of the first medicament delivery device 250 when the firstmedicament delivery device 250 is received within the first retainer214. In other embodiments, for example, the first retainer 214 and/orthe second retainer 216 can be a clip configured to engage a portion ofthe first medicament delivery device 250 and/or the second medicamentdelivery device 252, respectively, to retain the first medicamentdelivery device 250 and/or the second medicament delivery device 252 inthe internal region 212. In yet other embodiments, the first retainer214 and/or the second retainer 216 can be an elastic member, such as anelastic band configured to engage a portion of the first medicamentdelivery device 250 and/or the second medicament delivery device 252. Inyet other embodiments, the first retainer 214 and/or the second retainer216 can include a frangible member, such as a removable plastic coveringconfigured to retain the first medicament delivery device 250 and/or thesecond medicament delivery device 252 in the internal region 212.

In some embodiments, the first retainer 214 can be uniquely associatedwith the first medicament delivery device 250 and/or the second retainer214 can be uniquely associated with the second medicament deliverydevice 252. In this manner, the first medicament delivery device 250 canonly be associated with the first switch 236 and the second medicamentdelivery device 252 can only be associated with the second switch 237.Said another way, such an arrangement prevents second medicamentdelivery 252 from inadvertently being retained by the first retainer214, which could result in the electronic circuit system 230 outputtingthe first electronic output OP3 when the second medicament deliverydevice 252 is removed from the container 210 or vice-versa. Moreover, byusing the first retainer 214 and the second retainer 216, the internalregion 212 can be adapted to contain a variety of different medicamentdelivery devices having different sizes, shapes and/or characteristics.For example, in those embodiments in which the first retainer 214 is arecessed portion of the internal region 212, the shape of the recess canbe uniquely associated with a shape of the first medicament deliverydevice 250, thereby preventing the second medicament delivery device 252from being received within the first retainer 214. Similarly, in someembodiments, the second retainer 216 can be a recessed portion of theinternal region 212, of the type described above, having a shape toreceive at least a portion of the second medicament delivery device 252.

Although the retainers are described above as cooperating with themedicament delivery devices to retain the medicament delivery deviceswithin the internal region 212 of the container 210, in someembodiments, the first retainer 214 and/or the second retainer 216 canperform additional functions. For example, in some embodiments, thefirst retainer 214 can electronically couple an electronic circuitsystem (not shown in FIGS. 29-31) disposed on the first medicamentdelivery device 250 to the electronic circuit system 230. The electroniccircuit system included in the first medicament delivery device 250 canbe of the type shown and described above with reference FIGS. 1-25.Similarly, the second retainer 216 can electronically couple anelectronic circuit system (not shown in FIGS. 29-31) disposed on thesecond medicament delivery device 252 to the electronic circuit system230. In this manner, the first retainer 214 and/or the second retainer216 can be used as a battery charging port, a data exchange port or thelike.

FIG. 32 is a schematic illustration of a medical device 300 according toan embodiment of the invention. Because the medical device 300 issimilar in many respects to the medical devices shown and describedabove, the medical device 300 is shown in only one configuration. Themedical device 300 includes a container 310 including an electroniccircuit system 330 and defining an internal region 312. The internalregion 312 includes a first medicament delivery device 350 and a secondmedicament delivery device 352 of the types described above.

The electronic circuit system 330 is configured to output a firstelectronic output (not shown in FIG. 32), of the type described above,when the first medicament delivery device 350 is removed from theinternal region 312 of the container 310. Similarly, the electroniccircuit system 330 is configured to output a second electronic output(not shown in FIG. 32), of the type described above, when the secondmedicament delivery device 352 is removed from the internal region 312of the container 310.

Moreover, as shown in FIG. 32, the first medicament delivery device 350includes a label 354, such as, for example, a radio frequencyidentification (“RFID”) tag, configured to output a signal S that can bereceived by the electronic circuit system 330. In some embodiments, thesignal S can indicate the position of the first medicament deliverydevice 350 (e.g., whether the first medicament delivery device 350 isoutside the internal region 312). In other embodiments, the signal S caninclude information characterizing the first medicament delivery device350. For example, in some embodiments, the signal S can be associatedwith the contents of the first medicament delivery device 350 (e.g., theamount and type of medicament contained therein), an expiration date ofthe first medicament delivery device 350, a dosage of the firstmedicament delivery device 350 and/or a use instruction associated withthe first medicament delivery device 350. In this manner, the electroniccircuit system 330 can receive the signal S and produce the firstelectronic output (not shown in FIG. 32) to include informationcontained within the signal S. Said another way, this arrangement allowsthe electronic circuit system 330 to produce an electronic output thatis unique to the medicament delivery devices contained within thecontainer 310.

In some embodiments, for example, the first electronic output can beassociated with an audible message including information contained fromthe signal S, such as for example, the expiration date of the medicamentcontained within the first medicament delivery device 350. Such anaudible message can state, for example, “You have removed anauto-injector containing DOSE mg of Epinephrine. The expiration date ofthis device is EXPIRATION DATE. If the current date is later thanEXPIRATION DATE please select another auto-injector from within thecontainer.” In other embodiments, for example, the first electronicoutput can be a message providing the user with use instructions orother information contained within the signal S that is uniquelyassociated with the first medicament delivery device 350. For example,such a message can prompt a user to call a phone number unique to themanufacturer of the first medicament delivery device 350 for assistancebefore, during or after the use of the first medicament delivery device350. In yet other embodiments, as described in more detail herein, theelectronic circuit system 330 can automatically call such a phone numberwhen the first medicament delivery device 350 is removed from theinternal region 312 of the container 310.

The label 354 can be any device suitable for outputting the signal Sthat includes information associated with the first medicament deliverydevice 350 and that can be received by the electronic circuit system330. For example, in some embodiments, the label 354 can include apassive RFID tag. In other embodiments, the label can include an activeRFID tag.

In some embodiments, label 354 can include its own electronic circuitsystem, similar to the electronic circuit systems described above withreference to FIGS. 1-25. In such embodiments, the label 354 can producemultiple signals associated with the first medicament delivery device350 based on the ongoing status of the medicament delivery device 350 asdetermined by the electronic circuit system included within the label354. For example, in some embodiments, the first medicament deliverydevice 350 can include its own electronic circuit system having variousswitches, sensors or the like, such that when the user completes certainoperations (e.g., removing the needle guard, removing the safety tab,etc.), a signal S can be transmitted to the electronic circuit system330 of the container 310. The electronic circuit system 330 of thecontainer 310 can then output one or more electronic outputs of the typedescribed above to provide information to the user that is unique to thestatus of the first medicament delivery device 350.

Although the label 354 is shown and described as outputting a signal Sthat can be received by the electronic circuit system 330, in otherembodiments, the label 354 can be a passive device that does not outputan electronic signal, but rather, contains information associated withthe medicament delivery device 350 in a machine-readable format. Forexample, in such embodiments, the label 354 can include a bar codeportion containing information associated with the medicament deliverydevice 350. In other embodiments, the label 354 can include a magneticstrip containing information associated with the medicament deliverydevice 350.

The electronic circuit systems shown and described above can includemany components operatively coupled to perform the functions describedherein. For example, FIG. 33 is a schematic illustration of anelectronic circuit system 430 according to an embodiment of theinvention. The electronic circuit system 430 includes a processor 432operatively coupled to a memory device 434. The memory device 434 can beconfigured to store processor-readable code 435 instructing theprocessor 432 to perform the functions described herein. In someembodiments, the processor-readable code 435 can be modified and/orupdated as circumstances dictate. The electronic circuit system 430includes an input/output device 446 configured to receive electronicinputs from a first switch 436 and/or a second switch 437. In someembodiments, the input/output device 446 can receive inputs from an RFIDtag (as described above), the user's voice (e.g., through a microphone),a keyboard, a touch screen, a proximity sensor and/or any other suitabledevice. The input/output device 446 is also configured to provideelectronic signals to various output devices, such as, for example, avisual output device 442, an audio output device 444, a haptic outputdevice (not shown in FIG. 33) a wireless receiver (e.g., an RFID tag, acellular phone system or the like) and/or a wired receiver (e.g., awired network).

The visual output device 442 can be any suitable device for producingvisual indicia, such as, light-emitting diodes (LEDs), liquid-crystaldisplay (LCD) screens, optical polymers, fiber optic components or thelike. Similarly, the audio output device 444 can be any suitable devicefor producing sound, such as a micro-speaker a piezo-electric transduceror the like. Such sound output can include, for example, an alarm, aseries of beeps, recorded speech or the like.

In some embodiments, the electronic circuit system 430 includes anetwork interface 440 configured to operatively couple the electroniccircuit system 430 to a remote device 441, either via a wired connectionor via a wireless connection. The remote device 441 can be, for example,a remote communications network, a computer, a cell phone, a personaldigital assistant (PDA) or the like. Such an arrangement can be used,for example, to download replacement processor-readable code 435 from acentral network to the memory device 434. In some embodiments, theelectronic circuit system 430 can download information associated with amedicament delivery device, such as an expiration date, a recall notice,updated use instructions or the like.

The network interface 440 can also be configured to transmit informationfrom the electronic circuit system 430 to a central network, such as,for example, an emergency response network. In some embodiments, forexample, the electronic circuit system 430 can notify an emergencyresponder when a medicament delivery device is removed and/or actuated.In other embodiments, the electronic circuit system 430 can transmitinformation to a third party, such as a physician, an emergency contactand/or the manufacturer of a medicament device, when the medicamentdelivery device is removed and/or actuated. Such information caninclude, for example, the location of use, the date and/or time of useor the like.

As shown in FIG. 33, power is supplied to the electronic circuit system430 by a power source 448. The power source 448 can be any suitablepower source, such as, for example, a DC power source and/or an AC powersource. In some embodiments, for example, power can be provided to theelectronic circuit system 430 by an AC circuit within the building inwhich the medical device is located. In other embodiments, power can beprovided to the electronic circuit system 430 by one or more batteries.In yet other embodiments, power can be provided to the electroniccircuit system 430 by both an AC circuit (e.g. as the primary source ofpower) and by batteries (e.g. as the secondary source of power). In yetother embodiments, the electronic circuit system 430 can be powered byany suitable energy storage device, such as, for example, a capacitor,solar cell or the like.

The processor 432 can be a commercially-available processing devicededicated to performing one or more specific tasks. For example, in someembodiments, the microprocessor 432 can be a commercially-availablemicroprocessor, such as the Sonix SNC 12060 voice synthesizer.Alternatively, the processor 432 can be an application-specificintegrated circuit (ASIC) or a combination of ASICs, which are designedto perform one or more specific functions. In yet other embodiments, theprocessor 132 can be an analog or digital circuit, or a combination ofmultiple circuits.

The memory device 434 can include one or more types of memory. Forexample, in some embodiments, the memory device 434 can include a readonly memory (ROM) component and a random access memory (RAM) component.The memory device 432 can also include other types of memory suitablefor storing data in a form retrievable by the processor 432, forexample, electronically-programmable read only memory (EPROM), erasableelectronically-programmable read only memory (EEPROM) and/or flashmemory.

Although the medical devices shown and described herein include oneelectronic circuit system, in some embodiments, a medical device caninclude multiple electronic circuit systems configured to perform thefunctions described herein.

Although the containers shown and described above include multiplemedicament delivery devices, in some embodiments, a container caninclude only one medicament delivery device. For example, FIGS. 34-36show a medical device 500 including a container 510 that contains amedicament delivery device 550, such as, for example a pen injector oran auto-injector. As described above, the container 510 defines aninternal region 512 in which the medicament delivery device 550 iscontained. The container includes an electronic circuit system 530configured to produce one or more electronic outputs of the typedescribed above. More particularly, the electronic circuit system 530includes a speaker 544 and an LCD screen 542.

The container 510 also includes a movable portion 518, such as, forexample, a hinged lid, that has a first position (see FIG. 34) and asecond position (see FIGS. 35-36). When the movable portion 518 is inthe first position, the movable portion 518 covers the internal region512 of the container 510. Conversely, when the movable portion 518 is inthe second position, at least a portion of the internal region 512 ofthe container 510 is exposed. Said another way, when the movable portion518 is in the second position, the medicament delivery device 550 can beremoved from the internal region 512 of the container 510.

The electronic circuit system 530 is operatively coupled to a firstswitch 536 and a second switch 537. The first switch 536 is configuredto move between a first state (e.g., closed) and a second state (e.g.,opened) when the movable portion 518 moves between its first positionand its second position, as indicated by arrow E in FIG. 35. Theelectronic circuit system 530 is configured to output a first output OP5via the speaker 544 when the first switch 536 is moved from its firststate to its second state. The first output OP5 can be a recorded speechoutput associated with an identification of the medicament deliverydevice 550, an identification of patient symptoms (e.g., instructionsfor assessing the physical condition of the patient) and/or aninstruction for using the medicament delivery device 550. For example,in some embodiments the first output OP5 can state “You have activatedthe allergic reaction response kit. This kit includes an auto-injectorcontaining DOSE mg of Epinephrine. Before using this auto-injector,please ensure that the patient is exhibiting the following symptoms . .. .” Although described as an audible output, in other embodiments, thefirst output OP5 can be any type of electronic output as describedabove.

The second switch 537 is configured to move between a first state (e.g.,closed) and a second state (e.g., opened) when the medicament deliverydevice 550 is removed from the internal region 512 of the container 510,as indicated by the arrow F in FIG. 36. The electronic circuit system530 is configured to output a second output OP6 via the speaker 544and/or the LCD screen 542 when the second switch 537 is moved from itsfirst state to its second state. The second output OP6 can be, forexample, a recorded speech output and/or a video output associated withan identification of the medicament delivery device 550, anidentification of patient symptoms (e.g., instructions for assessing thephysical condition of the patient) and/or an instruction for using themedicament delivery device 550. For example, in some embodiments thesecond output OP6 can be an audio-visual output via both the speaker 544and the LCD screen 542 providing step-by-step instructions for using themedicament delivery device 550.

Although the movable member 518 is shown and described as being a hingedlid, in some embodiments, the movable member can be coupled to thecontainer in any suitable fashion. For example, in some embodiments, themovable member 518 can be a removable cover that is slidingly coupled tothe container. In other embodiments, the movable member 518 can be aremovable cover that is threadedly coupled to the container (i.e., aremovable cap). In yet other embodiments, the movable member 518 can bea removable cover that is coupled to the container via an interferencefit. In yet other embodiments, the movable member 518 can be a frangiblecover that is irreversibly removed from the container during use of themedical device. For example, in some embodiments the movable member 518can be a frangible cover that provides a tamperproof seal, a sanitaryseal, or the like.

Although the containers are shown and described above as being rigid,box-like containers, in other embodiments, a container can have anysuitable shape and/or flexibility. For example, in some embodiments, acontainer can be a flexible, pouch-like container. Such a container canbe more easily carried in certain circumstances, such as, for example atoutdoor events (e.g., children's camps, concerts, picnics or the like).In other embodiments, a container can be a tube configured to containall or a portion of a medicament delivery device. For example, FIGS.37-39 show a medical device 600 including a tube-shaped container 610and a retainer 618. The container 610 defines an internal region 612(see FIG. 39) in which at least a portion of a medicament deliverydevice 650 can be contained.

The retainer 618, which can be, for example, a mating tube-shaped lid,is movably coupled to the container 610 to retain the medicamentdelivery device 650 within the internal region 612. Said another way,the retainer 618 has a first position (FIG. 37) and a second position(FIG. 13). When the retainer 618 is in the first position, the retainer618 prevents the medicament delivery device 650 from being removed fromthe internal region 612 of the container 610. When the retainer 618 isin the second position, the medicament delivery device 650 can beremoved from the internal region 612 of the container 610.

The medical device 600 includes an electronic circuit system 630 coupledto the container 610. The electronic circuit system 630 includes aspeaker 644 and a light emitting diode (LED) 642 for providing anelectronic output associated with the use of the medicament deliverydevice 650, as described herein. In some embodiments, the electroniccircuit system can be, for example, a flexible circuit included in alabel coupled to an outer surface of the container 610, similar to theelectronic circuit systems described above with reference to FIGS. 1-25.

The electronic circuit system 630 is configured to output a firstelectronic output via the LED 642 and/or the speaker 644 when theretainer 618 is moved relative to the container 610, as indicated byarrows G and/or G′ in FIG. 38. As described above, the first electronicoutput can be associated with an identification of the medicamentdelivery device 650, an identification of a physical condition and/or aninstruction for using the medicament delivery device 650. For example,in some embodiments, the first electronic output can be associated withan audible message instructing a user in the use of the medicamentdelivery device 650. Such an audible message can state, for example,“You have activated an interactive auto-injector containing DOSE mg ofEpinephrine. Please remove the top of the container by twisting andpulling as indicated by the flashing arrow. After removing the top ofthe container, please remove the auto-injector from the container byfirmly pulling on the exposed end of the auto-injector.”

The electronic circuit system 630 can be prompted to output the firstelectronic output by a switch 636 configured to change states when theretainer 618 is moved relative to the container 610. The switch 636 canbe any suitable electronic switch having at least two states. Forexample, in some embodiments, the switch 636 can be a single-use“tear-through” switch, as described above with reference to FIGS. 1-25.In other embodiments, a switch can be a multi-use switch, such as amicroswitch.

Similarly, the electronic circuit system 630 is configured to output asecond electronic output via the LED 642 and/or the speaker 644 when themedicament delivery device 650 is removed from the internal region 612defined by the container 610, as shown by arrow H in FIG. 39. The secondelectronic output can be associated with an identification of themedicament delivery device 650, an identification of a physicalcondition and/or an instruction for using the medicament delivery device650. For example, in some embodiments, the second electronic output canbe an audible message stating, “To activate the auto-injector, firstremove the needle guard. The needle guard is at the bottom of theauto-injector and contains the number one inside of an arrow pointingdownward. Remove the needle guard by pulling in the direction of thearrow.”

As shown in FIG. 39, the medicament delivery device 650 includes a label654 containing information associated with the medicament deliverydevice 650 arranged in a machine-readable format. The electronic circuitsystem 630 is configured to receive (e.g., “read”) the informationcontained in the label 654 and include at least a portion of theinformation in the first electronic output and/or the second electronicoutput. In this manner, the electronic circuit system 630 can beconfigured to produce an electronic output that is unique to themedicament delivery device 650 contained within the container 610. Thisarrangement allows the container 610 to be reused with any number ofdifferent medicament delivery devices 650. Moreover, this arrangementallows the container 610 to track the usage of a chronic-care medicamentdelivery devices. For example, in some embodiments, the electroniccircuit system 630 can track each use of the medicament delivery device650 and log such information on the label 654.

The label 654 can be any device suitable for containing informationassociated with the medicament delivery device 650 in a machine-readableformat. For example, in some embodiments, the label 654 can include abar code portion containing information associated with the medicamentdelivery device 650. In other embodiments, the label 654 can include amagnetic strip containing information associated with the medicamentdelivery device 650. In yet other embodiments, the label 654 can includea passive RFID tag containing information associated with the medicamentdelivery device 650. In yet other embodiments, the label 654 can includean active RFID tag containing information associated with the medicamentdelivery device 650.

Although the retainer 618 is shown as covering the internal region 612defined by the container 610, in some embodiments, the retainer 618 canallow access to the internal region 612 while still retaining themedicament delivery device 650 within the internal region 612. Forexample, in some embodiments, the retainer 618 can be a clip, a strap orthe like.

Although the medicament delivery device 650 is shown in FIGS. 37-38 asbeing disposed entirely within the container 610 and the retainer 618,in some embodiments, only a portion of the medicament delivery device650 is disposed within the container 610 and/or the retainer 618. Forexample, in some embodiments, a container can be a sleeve configured tobe disposed about a portion of a medicament delivery device, such as achronic care pen injector. The retainer can function to retain the peninjector within the sleeve and/or to prevent the pen injector from beingactuated (e.g., the retainer can act as a locking member). In use, theuser can activate the electronic circuit system by depressing a startbutton disposed on the container. Alternatively, in some embodiments,the electronic circuit system can be activated by removing the retainerfrom the pen injector and/or the container. In yet other embodiments,the electronic circuit system can be activated by moving the peninjector relative to the container (i.e., twisting the pen injectorwithin the container). Upon activation, the electronic circuit systemthen “reads” a label and outputs a first electronic output and/or asecond electronic output, as described above.

Although the medical devices are shown and described above as includingmedicament delivery devices, such as, for example, medical injectors,inhalers or the like, in other embodiments, a medical device can includea simulated medicament delivery device. FIG. 40 is a schematicillustration of a simulated medicament delivery device 102 according toan embodiment of the invention. In some embodiments, the simulatedmedicament delivery device 102 can correspond to an actual medicamentdelivery device (i.e., a device actually configured to deliver amedicament, not shown in FIG. 40) and can be used, for example, to traina user in the operation of the corresponding actual medicament deliverydevice.

The simulated medicament delivery device 102 includes an electroniccircuit system 170 configured to output an electronic output OP10associated with the use of the simulated medicament delivery device 102.As described herein, in some embodiments, for example, the electronicoutput OP10 can be associated with an identification of the simulatedmedicament delivery device 102, an identification of certain componentsof the simulated medicament delivery device 102 (e.g., a top portion, asafety lock, or the like), an identification of a physical condition forwhich a patient may require the medicament delivery device (not shown inFIG. 40) and/or an instruction for using the simulated medicamentdelivery device 102 and/or the corresponding actual medicament deliverydevice (not shown in FIG. 40).

Moreover, the electronic output OP10 can include any type of electronicoutput and/or signal discussed herein, such as, for example, a visualoutput, an audible output and/or a haptic output. For example, in someembodiments, the electronic output OP10 can be a signal associated withan audible message (e.g., recorded speech) identifying the simulatedmedicament delivery device 102. Such an audible message can state, forexample, “You have removed an auto-injector trainer that will teach youhow to use an actual auto-injector. This trainer does not contain anymedicament. If this an actual emergency, please dial 911 or locate anactual auto-injector.” In some embodiments, an audible output caninstruct a user in the use of the simulated medicament delivery device102. Such an audible message can state, for example, “The first step inusing an actual auto-injector is to identify the key features of theauto-injector. The key features of the auto-injector are the safety lockand the actuator button . . . .” In other embodiments, the electronicoutput OP10 can be associated with a visual indicator that identifiesone or more components of the simulated medicament delivery device 102.

In some embodiments, the user can activate the electronic circuit system170 by pushing the start button 171, which prompts the electroniccircuit system 170 to output at least the electronic output OP10. Insome embodiments, for example, when the start button 171 is actuated,the electronic circuit system 170 can output a predetermined sequence ofelectronic outputs. As described above, in some embodiments, the startbutton 171 can activate the electronic circuit system 170 by providingan input to a processor (not shown in FIG. 40). In other embodiments,the start button 171 can activate the electronic circuit system 170 byplacing a battery (not shown in FIG. 40) in electronic communicationwith a portion of the electronic circuit system 170.

The simulated medicament delivery device 102 can simulate the actualmedicament delivery device in any number of ways. For example, in someembodiments, the simulated medicament delivery device 102 can have ashape corresponding to a shape of the actual medicament delivery device,a size corresponding to a size of the actual medicament delivery deviceand/or a weight corresponding to a weight of the actual medicamentdelivery device. Moreover, in some embodiments, the simulated medicamentdelivery device 102 can include components that correspond to thecomponents of the actual medicament delivery device. In this manner, thesimulated medicament delivery device 102 can simulate the look, feel andsounds of the actual medicament delivery device. For example, in someembodiments, the simulated medicament delivery device 102 can includeexternal components (e.g., a housing, a needle guard, a sterile cover, asafety lock or the like) that correspond to external components of theactual medicament delivery device. In some embodiments, the simulatedmedicament delivery device 102 can include internal components (e.g., anactuation mechanism, a spring, a compressed gas source, a medicamentcontainer or the like) that correspond to internal components of theactual medicament delivery device.

In some embodiments, however, the simulated medicament delivery device102 can be devoid of a medicament and/or those components that cause themedicament to be delivered (e.g., a needle, a nozzle or the like). Inthis manner, the simulated medicament delivery device 102 can be used totrain a user in the use of the actual medicament delivery device withoutexposing the user to a needle and/or a medicament. Moreover, thesimulated medicament delivery device 102 can have features to identifyit as a training device to prevent a user from mistakenly believing thatthe simulated medicament delivery device 102 can be used to deliver amedicament. For example, in some embodiments, the simulated medicamentdelivery device 102 can be of a different color than a correspondingactual medicament delivery device. Similarly, in some embodiments, thesimulated medicament delivery device 102 can include a label clearlyidentifying it as a training device.

The simulated medicament delivery device 102 can simulate any number ofmedicament delivery devices. For example, in some embodiments, thesimulated medicament delivery device 102 can simulate a medicalinjector, such as an auto-injector, a pen injector or the like. In otherembodiments, the simulated medicament delivery device 102 can simulatean inhaler. In yet other embodiments, the simulated medicament deliverydevice 102 can simulate a transdermal delivery device.

In some embodiments, the simulated medicament delivery device 102 canrepeatedly simulate the actual medicament delivery device. For example,in some embodiments, after the simulation is complete the electroniccircuit system can be reset, for example, by pushing the start button171. In this manner, the simulated medicament delivery device 102 can beconfigured to repeat the electronic output OP10 or predeterminedsequence of electronic outputs during subsequent simulations.

FIG. 41 is a perspective view of a simulated auto-injector 202 accordingto an embodiment of the invention. The simulated auto-injector 202 isconfigured to simulate an auto-injector (not shown in FIG. 41) similarto the auto-injectors described herein and in U.S. patent applicationSer. No. 11/562,061, entitled “Devices, Systems and Methods forMedicament Delivery,” filed Nov. 21, 2006, which is incorporated hereinby reference in its entirety.

The simulated auto-injector 202 includes a housing 285 having a proximalend portion 292 and a distal end portion 293. A simulated needle guardassembly 286 is removably coupled to the distal end portion 293 of thehousing 285. The simulated needle guard assembly 286 is configured tosimulate an actual needle guard assembly (e.g., needle guard assembly4810 shown and described above with reference to FIGS. 5, 12-14).Similarly, a simulated safety lock 287 is removably coupled to thedistal end portion 293 of the housing 285. The simulated safety lock 287is configured to simulate an actual safety lock (e.g., safety lock 4710shown and described above with reference to FIGS. 5, 12-14).

The simulated auto-injector 202 includes an electronic circuit system270 and a label 262. The label 262 can be any suitable label of the typedescribed herein. In some embodiments, for example, the label 262 caninclude at least a portion of the electronic circuit system 270 (i.e.,portions of an electronic conductors, portions of a printed circuitboard, a battery, an LED or the like). In other embodiments, the label262 can be devoid of any portion of the electronic circuit system 270.

The electronic circuit system 270 includes a start button 271, a speaker274 and two LEDs 272A, 272B. The electronic circuit system 270 can beany electronic circuit system of the type shown and described herein.For example, in some embodiments, the electronic circuit system 270 caninclude a flexible printed circuit board to electronically coupled thecomponents contained therein. Moreover, the electronic circuit system270 can be disposed in any suitable manner relative to the housing 285.In some embodiments, for example, the electronic circuit system 270 canbe integrated with the simulated medicament delivery device 202. Saidanother way, in some embodiments, the electronic circuit system 270 canbe contained within the housing 285 and/or the electronic circuit system270 can be assembled concurrently and/or using common processes with thesimulated medicament delivery device 202. In other embodiments, theelectronic circuit system 270 can be partially-integrated with thesimulated medicament delivery device 202. Said another way, in someembodiments, at least a portion of the electronic circuit system 270 canbe contained within the housing 285 and/or at least a portion of theelectronic circuit system 270 can be assembled concurrently and/or usingcommon processes with the simulated medicament delivery device 202. Inyet other embodiments, the electronic circuit system 270 can be disposedentirely on an outer surface of the housing 285 and/or the electroniccircuit system 270 can be assembled using separate processes from thoseused to manufacture the simulated medicament delivery device 202. Insome embodiments, for example, the electronic circuit system can beincluded in the label 262. In other embodiments, the label 262 can beused to secure the electronic circuit system to an outer portion of thehousing 285.

To activate the electronic circuit system 270, the user first pushes thestart button 271. As described above, when actuated, the electroniccircuit system 270 can output one or more electronic outputs. Forexample, in some embodiments, an electronic output can be associatedwith an audio and/or a visual output used to describe the features ofand/or identify component of the simulated medicament delivery device202. For example, in some embodiments, the first LED 272A, the output ofwhich is shaped as the numeral “1,” can output a flashing light of afirst color while the speaker 274 simultaneously outputs a recordedvoice message stating “the simulated needle guard is identified by theFIRST COLOR flashing light shaped as the numeral one.” Similarly, thesecond LED 272BA, the output of which is shaped as the numeral “2,” canoutput a flashing light of a second color different than the first colorwhile the speaker 274 simultaneously outputs a recorded voice messagestating “the simulated safety lock is identified by the SECOND COLORflashing light shaped as the numeral two.” In this manner, theelectronic circuit system 270 can provide both audible and visualinstructions to assist the user in the operation of the simulatedmedicament delivery device 202.

In some embodiments, the electronic circuit system 270 can output atleast one electronic output in response to a switch (not shown in FIG.41) being moved between a first state and a second state. For example,similar to the needle guard assembly 4810 shown and described above withreference to FIG. 12, the simulated needle guard assembly 286 caninclude an actuator configured to actuate a switch contained within theelectronic circuit system 270. The switch can be any suitable switch ofthe types shown and described above. For example, in some embodiments, aswitch can be a “tear-through” switch configured to move irreversiblyfrom a first state to a second state. In other embodiments, a switch canbe a microswitch configured to repeatedly move between a first state anda second state. In this manner, the electronic circuit system 270 canoutput instructions when the user moves the simulated needle guardassembly 286 relative to the housing 285. Such instructions can state,for example, “You have now removed the needle guard assembly. The nextstep is to remove the safety lock. Please pull the safety lock asindicated by the flashing arrow.” In a similar manner, the simulatedsafety lock 287 can include an actuator configured to actuate a switchcontained within the electronic circuit system.

Although the simulated medicament delivery device 202 is shown asincluding a start button 271 to activate the electronic circuit system(not shown in FIG. 41), in other embodiments, an electronic circuitsystem 270 can be activated by any suitable means. For example, in someembodiments, the electronic circuit system can be activated by removingthe simulated needle guard assembly 286, as described above withreference to FIG. 12. In other embodiments, the electronic circuitsystem 270 can be activated by removing the simulated safety lock 287,as described above with reference to FIG. 13. In yet other embodiments,the electronic circuit system 270 can be activated by removing thesimulated medicament delivery device 202 from a container (not shown inFIG. 41), as shown and described above with reference to FIGS. 26-39.

FIGS. 42-46 are front views of a simulated auto-injector 302 accordingto an embodiment of the invention. The simulated auto-injector 302includes a housing 385 having a proximal end portion 392 and a distalend portion 393. The housing defines a window 389, which can, forexample, simulate a status window of a corresponding actualauto-injector (not shown in FIGS. 42-46), as described below. Asimulated needle guard assembly 386 is removably coupled to the distalend portion 393 of the housing 385. Similarly, a simulated safety lock387 is disposed at the distal end portion 393 of the housing (see FIG.43). The proximal end portion 392 of the housing 385 includes asimulated injector actuation button 388. The simulated injectoractuation button 388 is configured to simulate an actuation button ofthe corresponding auto-injector.

The simulated auto-injector 302 includes an electronic circuit system370 and a label 362. The label 362 can include a textual indicia 363 andcan be any suitable label of the type described herein. In someembodiments, for example, the label 362 can include at least a portionof the electronic circuit system 370 (i.e., portions of an electronicconductor, portions of a printed circuit board, a battery, an LED or thelike). In other embodiments, the label 362 can be devoid of any portionof the electronic circuit system 370.

The electronic circuit system 370 includes a start button 371, a speaker374 and three visual output devices 372A, 372B and 372C. The visualoutput devices 372A, 372B and 372C can be, for example, LEDs, LCDs,organic polymer devices and/or fiber optic devices. The electroniccircuit system 370 also includes a force sensor 377 (shown in FIG. 43)and a position sensor (not shown in FIGS. 42-46). The above describedcomponents can be electronically coupled together by any suitablemechanism, such as, for example a printed circuit board of the typesshown and described herein.

As described above, to activate the electronic circuit system 370, theuser pushes the start button 371. When actuated, the electronic circuitsystem 370 can output one or more electronic outputs. For example, insome embodiments, the first visual output device 372A can output aflashing light while the speaker 374 simultaneously outputs a recordedvoice message stating “Please remove the simulated needle guard, whichis at the end of the injector as indicated by the flashing light.”

As illustrated by arrow KK in FIG. 43, the simulated needle guard 386 isremoved by moving it along the longitudinal axis of the housing 385.When the simulated needle guard 386 is removed, the portion of theelectronic circuit system 370 that includes the first visual outputdevice 372A is no longer electronically coupled to the remainder of theelectronic circuit system 370. Accordingly, the first visual outputdevice 372A becomes deactivated when the simulated needle guard 386 isremoved. Moreover, the terminals 375 of the electronic conductors 379can form a portion of a switch, such that when the simulated needleguard 386 is removed, the switch changes from a first state to a secondstate, thereby prompting the electronic circuit system 370 to output anadditional electronic output. For example, in some embodiments, thespeaker 374 can output a recorded voice message stating “Please placethe simulated auto-injector against your thigh. Do not tilt thesimulated auto-injector. When in the proper position, please pressfirmly against the thigh before actuating the auto-injector.”

In addition to prompting the electronic circuit system 370 to outputadditional visual and/or audible outputs, the removal of the simulatedneedle guard 386 can also activate the position sensor (not shown inFIGS. 42-46). The position sensor can be any suitable sensor for sensinga position, location and/or orientation of the simulated auto-injector302. For example, in some embodiments, the position sensor can beconfigured to sense the angle Θ between the longitudinal axis of thehousing 385 and the surface of the target T (see FIG. 44). In otherembodiments, the position sensor can be configured to sense the absoluteangle of the longitudinal axis of the housing based on gravity. In yetother embodiments, the position sensor can be capacitance sensor, atemperature sensor, an optical sensor or any other suitable sensor fordetermining when the distal end 393 of the simulated medicament deliverydevice 302 is in contact with the target T. In this manner, the positionsensor can provide feedback to the user to ensure that the simulatedmedicament delivery device 302 is correctly positioned relative to thetarget T.

Similarly, when the user presses the simulated medicament deliverydevice 302 against the target T, as shown by the arrow LL in FIG. 44,the force sensor 377 can sense the force and/or pressure between thetarget T and the simulated safety lock 387. In this manner, the forcesensor 377 can provide feedback to the user to ensure that the simulatedmedicament delivery device 302 is pressed against the target T withsufficient force to move the safety lock of an actual medicamentdelivery device (not shown in FIGS. 42-46). The force sensor 377 canalso provide feedback to the user to ensure that the simulatedmedicament delivery device 302 is not pressed too firmly against thetarget T. The force sensor 377 can be any sensor suitable for sensing aforce and/or pressure, such as for example, a strain-gauge load sensor,a piezo-electric sensor or the like.

In some embodiments, after the simulated medicament delivery device 302is correctly positioned with sufficient force against the target T, theforce sensor 377 can prompt the electronic circuit system 370 to outputan additional electronic output or sequence of electronic outputs. Forexample, in some embodiments, the second visual output device 372B canoutput a flashing light while the speaker 374 simultaneously outputs arecorded voice message stating “The simulated auto-injector is nowcorrectly positioned against your body. Please press the injectoractuation button at the top of the auto-injector as indicated by theflashing light.”

In some embodiments, the electronic circuit system 370 can include atimer (not shown in FIGS. 42-46) to determine the duration of any of thevarious operations discussed herein. In this manner, the electroniccircuit system 370 can repeat a previous electronic output if no actionhas been sensed within a predetermined amount of time. For example, insome embodiments, the electronic circuit system 370 can repeat theelectronic output prompting the user to remove the simulated needleguard 386 if a predetermined time period has elapsed after the startbutton 371 is pushed and before the simulated needle guard 386 isremoved. In some embodiments, the electronic circuit system 370 canaugment the electronic output prompting the user to remove the simulatedneedle guard 386 if a predetermined time period has elapsed after thestart button 371 is pushed and before the simulated needle guard 386 isremoved. The electronic output can be augmented, for example, byautomatically increasing the volume of the audible output, changing thecharacteristics (e.g., the color, flash rate or the like) of the visualoutputs or the like.

In other embodiments, the electronic circuit system 370 can output anelectronic output to instruct the user to move to the next operationafter a predetermined amount of time has elapsed. For example, in someembodiments, the speaker 374 can output a recorded voice message stating“Release the actuation button. Do not continue to hold the actuationbutton down” when the duration between when the user presses thesimulated injector actuation button 388 (as shown by arrow MM in FIG.45) and when the user releases the simulated injector actuation button388 (as shown by arrow NN in FIG. 46) exceeds a predetermined duration.In this manner, the electronic circuit system 370 can provide feedbackto the user to ensure that the simulated medicament delivery device 302is used properly.

As shown in FIG. 46, the third visual output device 372C is visiblethrough the window 389 defined by the housing 385. In some embodiments,the third visual output device 372C and the window 389 can collectivelysimulate a status window of the actual medicament delivery device (notshown in FIG. 46). For example, in some embodiments, the third visualoutput device 372C can gradually change color to simulate an associatedcolor change of a status window that alerts a user when an actualinjection is complete.

Although the simulated medicament delivery devices are shown anddescribed as including external components and/or internal components tosimulate actual medicament delivery devices, in some embodiments, asimulated medicament delivery device can be devoid of certaincomponents, such as, for example, springs, actuation mechanisms or thelike. For example, in some embodiments, a simulated medicament deliverydevice can include an electronic circuit system configured to output anelectronic output to simulate any one of a tactile sensation, an audiblesensation, a visual sensation, an olfactory sensation and/or a tastesensation associated with a use of the medicament delivery device. Inthis manner, the simulated medicament delivery device can simulate amedicament delivery device without mechanical components and/ormedicament, which can be make the simulated medicament delivery deviceexpensive, unsafe to use, difficult to use, difficult to reset forrepeated use or the like.

FIG. 47 is a schematic illustration of an electronic circuit system 470according to an embodiment of the invention configured to cooperate witha housing (not shown in FIG. 47) to simulate a medicament deliverydevice (not shown in FIG. 47). The electronic circuit system 470includes a processor 478 operatively coupled to a memory device 473, ofthe types shown and described above with reference to FIGS. 3 and 33.The memory device 473 can be configured to store processor-readable code405 instructing the processor 478 to perform the functions describedherein. In some embodiments, the processor-readable code 405 can bemodified and/or updated as circumstances dictate.

The electronic circuit system 470 includes an input/output device 477configured to receive electronic inputs from a switch 475 and/or asensor 476, as described above. In some embodiments, the input/outputdevice 477 can receive inputs from any suitable device, such as an RFIDtag (as described above), the user's voice (e.g., through a microphone),a start button 471 or the like. The input/output device 477 is alsoconfigured to output electronic signals to various output devices, suchas, for example, a visual output device 472, an audio output device 474,a haptic output device 494, an olfactory output device 495, a tasteoutput device 496, a wireless receiver (e.g., an RFID tag, a cellularphone system or the like) and/or a wired receiver (e.g., a wirednetwork).

The visual output device 472 can be any suitable device for producingvisual indicia, such as, light-emitting diodes (LEDs), liquid-crystaldisplay (LCD) screens, optical polymers, fiber optic components or thelike. In this manner, the electronic circuit system 470 can simulate aparticular visual feature of a medicament delivery device, such as, forexample, a change in the color of a status window.

Similarly, the audio output device 474 can be any suitable device forproducing sound, such as a micro-speaker, a piezo-electric transducer orthe like. Such audible output can include, for example, an alarm, aseries of beeps, recorded speech or the like. In this manner, theelectronic circuit system 470 can simulate a particular audible featureof a medicament delivery device, such as, for example, a series ofclicks associated with the actuation of the medicament delivery deviceand/or the delivery of the medicament.

The haptic output device 494 can be any suitable device for producing ahaptic output, such as a vibrator, a piezo-electric device, a heater, acooler or the like. In this manner, the electronic circuit system 470can simulate a particular feel of a medicament delivery device. Forexample, in some embodiments, a simulated medicament delivery device canbe configured to simulate a transdermal medicament delivery device bysimulating the thermal feel of a medicament delivery area against theskin. In other embodiments, a simulated medicament delivery device canbe configured to simulate an auto-injector by simulating the vibrationassociated with the actuation of the auto-injector.

The olfactory output device 495 can be any suitable device for producinga scent output. In this manner, the electronic circuit system 470 cansimulate a particular smell associated with a medicament deliverydevice. For example, in some embodiments, a simulated medicamentdelivery device can be configured to simulate an inhaler by simulatingthe smell of a medicament as it is being delivered orally.

Similarly, the taste output device 495 can be any suitable device forproducing a simulated taste. In this manner, the electronic circuitsystem 470 can simulate a particular taste associated with a medicamentdelivery device. For example, in some embodiments, a simulatedmedicament delivery device can be configured to simulate an inhaler bysimulating the taste of a medicament as it is being delivered orally.

In some embodiments, the electronic circuit system 470 can include anetwork interface 409 configured to operatively couple the electroniccircuit system 470 to a remote device (not shown in FIG. 47), asdescribed above. The network interface 409 can also be configured totransmit information from the electronic circuit system 470 to a centralnetwork, such as, for example, a doctor's office, as described above.

In some embodiments, a simulated medicament delivery device can beincluded in a kit. FIG. 48 is a schematic illustration of a medicaldevice 501 according to an embodiment of the invention. The medicaldevice 501 includes a container 503, a medicament delivery device 504and a simulated medicament delivery device 502. The container 503, whichincludes a first electronic circuit system 570A, can be similar to thecontainers shown and described above with reference to FIGS. 26-39. Themedicament delivery device 502, which includes a label 506 can besimilar to the medicament delivery devices shown and described herein.Similarly, the simulated medicament delivery device 502, which includesa second electronic circuit system 570B, can be similar to the simulatedmedicament delivery devices shown and described above with reference toFIGS. 40-47.

The first electronic circuit system 570A can output an electronic outputOP11, of the type described above, when a user presses a start button(not shown in FIG. 48), when the container 503 is opened, when themedicament delivery device 504 is removed from the container and/or whenthe simulated medicament delivery device 502 is removed from thecontainer. Moreover, the label 506 can contain information associatedwith the medicament delivery device 504 in a machine-readable format.Accordingly, the first electronic circuit system 570A can receive (e.g.,“read”) the information contained in the label 506 and include at leasta portion of the information in the electronic output OP11. In thismanner, as described above, the first electronic circuit system 570A canbe configured to produce an electronic output OP11 that is unique to themedicament delivery device 504 contained within the container 503. Forexample, in some embodiments, the electronic output OP11 can notify auser when the medicament delivery device 504 has been removed from thecontainer 503 and alert the user to the presence of the simulatedmedicament delivery device 502.

Similarly, the second electronic circuit system 570B can output anelectronic output OP12, of the type described above, when a user pressesa start button (not shown in FIG. 48), when the simulated medicamentdelivery device 502 is removed from the container 503 or the like.Moreover, similar to the function of the first electronic circuit system570A, the second electronic circuit system 570B can also receive (e.g.,“read”) the information contained in the label 506 and include at leasta portion of the information in the electronic output OP12. For example,in some embodiments, the electronic output OP11 can notify a user of astatus (e.g., the dosage, expiration date or the like) of the medicamentdelivery device 504.

In some embodiments, the second electronic circuit system 570B canoutput a signal S12 that can be received by the first electronic circuitsystem 570A. In some embodiments, the signal S12 can indicate that thesimulated medicament delivery device 502 has been removed from thecontainer 503. In other embodiments, the signal S12 can includeinformation associated with the use of the simulated medicament deliverydevice 502 and/or the medicament delivery device 504. For example, insome embodiments, the signal S12 can be associated with anidentification of the simulated medicament delivery device 502, anidentification of certain components of the simulated medicamentdelivery device 502 and/or a status of the simulated medicament deliverydevice 502, as described above. In this manner, the first electroniccircuit system 570A can receive the signal S12 and produce theelectronic output OP11 to include information contained within thesignal S12. Said another way, this arrangement allows the firstelectronic circuit system 570A and the second electronic circuit system570B to cooperatively output the electronic output OP11. For example, insome embodiments, the simulated medicament delivery device 502 canoutput a signal S12 that prompts the first electronic circuit system570A to augment the electronic output OP12 (e.g., by displaying anoutput on a larger LCD screen or the like) previously output by thesimulated medicament delivery device 502.

Similarly, in some embodiments, the first electronic circuit system 570Acan output a signal S11 that can be received by the second electroniccircuit system 570B. In some embodiments, the signal S11 can include,for example, updated use instructions that have been received by thefirst electronic circuit system 570A (e.g., via a wireless network). Asdescribed above, the second electronic circuit system 570B can receivethe signal S11 and produce the electronic output OP12 to includeinformation contained within the signal S11. This arrangement allows thefirst electronic circuit system 570A and the second electronic circuitsystem 570B to cooperatively to produce the electronic output OP12.

Although the first electronic circuit system 570A and the secondelectronic circuit system 570B are each shown and described as beingconfigured to output at least an electronic output (e.g., OP11 and OP12,respectively) and a signal (e.g., S11 and S12, respectively), the use ofseparate terms is made for clarity. Accordingly, there is no distinctionbetween signals and electronic outputs.

Although the medicament delivery device 504 is shown and described asincluding a label 506 containing information associated with themedicament delivery device 504 in a machine-readable format, in someembodiments, the medicament delivery device can include its ownelectronic circuit system. In such embodiments, the electronic circuitsystem of the medicament delivery device can cooperate with the firstelectronic circuit system 570A and/or the second electronic circuitsystem 570B to produce various electronic outputs, as described above.

In some embodiments, the medical device 501 can include a simulatedtarget (not shown in FIG. 48) to simulate a portion of a body for usewith the simulated medicament delivery device 502. In some embodiments,the simulated target can be a skin pad that simulates a portion of athigh or an arm. In other embodiments, the simulated target can be astrap or band that is placed around a portion of the user's body toprovide a target for use with the simulated medicament delivery device502 and/or the medicament delivery device 504. In some embodiments, asimulated target can include its own electronic circuit system. In suchembodiments, for example, the simulated target can include one or moreLEDs to provide a visual indication of a location for receiving amedicament, a force sensor to sense the force and/or pressure betweenthe simulated target and the simulated medicament delivery device 502,or the like.

Although the labels are shown and described above as including a portionof an electronic circuit system and/or securing an electronic circuitsystem to an outer portion of a simulated medicament delivery device, insome embodiments, a label and a housing of a simulated medicamentdelivery device can cooperatively contain an electronic circuit system.For example, FIG. 49 is a perspective view of a simulated medicamentdelivery device 602 according to an embodiment of the invention. Thesimulated medicament delivery device 602 includes a housing 685, anelectronic circuit system 670 and a label 662.

The label 662 includes a first surface 664 and a second surface 665. Thefirst surface 664 is configured to be coupled to the housing 685 of thesimulated medicament delivery device 602. In some embodiments, forexample, the first surface 664 can include an adhesive to secure thelabel 662 to the housing 685. The second surface 665 includes an indicia663, which can be for example, a textual indicia (e.g., a name of thedevice, use instructions or the like) or a symbolic indicia (e.g., anarrow pointing to a start button). Although the first surface 664 isshown as being opposite the second surface 665, in other embodiments,the first surface 664 and the second surface 665 can be adjacent eachother and/or co-planar.

The label 662 also includes a rigid portion 667 disposed between twoflexible portions 668A and 668B. The flexible portions 668A and 668B areconfigured to conform to the surface of the housing 685, as shown by thearrows PP and QQ in FIG. 49. The rigid portion 667 includes theelectronic circuit system 670. The rigid portion 667 can be constructedfrom any suitable material, such as, for example, plastic, that canprotect the electronic circuit system 670. Conversely, the flexibleportions 668A and 668B can be constructed from any suitable flexiblematerial, such as, for example, paper, flexible foam, Mylar®, Kapton® orthe like. This arrangement allows the label 662 to be wrapped around thehousing 685 to securely couple the electronic circuit system 670 withinan opening 690 defined by the housing 685. Said another way, the label662 and the housing 685 cooperatively define an enclosed region 690within which at least a portion of the electronic circuit system 670 canbe disposed.

Although the electronic circuit systems are shown and described above asoutputting a single electronic output in response to an input (e.g., themovement of a safety lock, pressing a start button, the removal of amedicament delivery device, the change in position of a hinged lid,etc.), in some embodiments, an electronic circuit system can output asequence of electronic outputs in response to such an input. In someembodiments, for example, when a medicament delivery device is removedfrom a container, an electronic circuit system disposed on themedicament delivery device and/or container can output a predeterminedsequence of use instructions over a predetermined time period. Forexample, upon removing the medicament delivery device, the firstinstruction can be an audible output indicating the type of medicamentdelivery device removed. After a predetermined time period, theelectronic circuit system can then output a second instruction, whichcan be a visual output instructing the user in how to diagnose thepatient and/or prepare the patient for the medicament. In a similarmanner, the electronic circuit system can provide additional outputs toinstruct the user in the use of the medicament delivery device.Moreover, in some embodiments, the electronic circuit system can outputan electronic output instructing the user in post-use procedures, suchas for example, the disposal of the medicament delivery device,instructions for follow-up treatment or the like.

Although the electronic circuit systems are shown and described above asoutputting recorded speech in English, in other embodiments, theelectronic circuit system can output recorded speech in any language. Inyet other embodiments, the electronic circuit system can output recordedspeech in multiple languages. In yet other embodiments, the user canselect the language in which the recorded speech is to be output.

For example, although electronic circuit systems are shown and describedabove as outputting one or more outputs directed towards a single,immediate user, in some embodiments, an electronic circuit system canoutput multiple outputs directed towards multiple different classes ofusers. For example, in some embodiments, an electronic circuit systemcan output a first electronic output to the immediate user and secondelectronic output to a remotely located emergency response team. In suchembodiments, the second electronic output can be, for example, a phonecall, a page, an e-mail or the like. For example, in some embodiments,the second electronic output can be an e-mail to the parents and/orcaregivers of a child. Moreover, such a second electronic output can betransmitted either wirelessly or through a wired network.

Although the electronic circuit systems are shown and described above asoutputting one or more outputs in response to one or more switches, inother embodiments an electronic circuit system can output an electronicoutput in response to any number of different inputs. For example, insome embodiments, an electronic circuit system can output an electronicoutput based on input from the user provided via a keyboard, a touchscreen, a microphone or any other suitable input device. In this manner,the electronic outputs can be produced in response to direct feedbackfrom the user.

Some embodiments of the invention relate to a computer storage productwith a computer-readable medium having instructions or computer codethereon for performing various computer-implemented operations. Themedia and computer code may be those specially designed and constructedfor the purposes of the invention, or they may be of the kind well knownand available to those having skill in the computer software arts.Examples of computer-readable media include, but are not limited to:magnetic storage media such as hard disks, floppy disks, and magnetictape; optical storage media such as Compact Disc/Digital Video Discs(“CD/DVDs”), Compact Disc-Read Only Memories (“CD-ROMs”), andholographic devices; magneto-optical storage media such as flopticaldisks; carrier wave signals; and hardware devices that are speciallyconfigured to store and execute program code, such asApplication-Specific Integrated Circuits (“ASICs”), Programmable LogicDevices (“PLDs”), and ROM and RAM devices. Examples of computer codeinclude, but are not limited to, micro-code or micro-instructions,machine instructions, such as produced by a compiler, and filescontaining higher-level instructions that are executed by a computerusing an interpreter. For example, an embodiment of the invention may beimplemented using Java, C++, or other object-oriented programminglanguage and development tools. Additional examples of computer codeinclude, but are not limited to, control signals, encrypted code, andcompressed code.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments amedical device can include a container including an electronic circuitsystem, two or more medicament delivery devices and a movable portion.In such embodiments, each of the medicament delivery devices can beassociated with a switch. Moreover, the movable portion can also beassociated with a switch. In this manner, the electronic circuit systemcan be configured to output a first electronic output when the movableportion is moved, a second electronic output when the first medicamentdelivery device is removed from the container and a third electronicoutput when the second medicament delivery device is removed from thecontainer.

Although the simulated medicament delivery devices and the actualmedicament delivery devices are shown and described above as beingseparate, in some embodiments a single device can contain certainfeatures and perform certain functions of both a simulated medicamentdelivery device and an actual medicament delivery device. For example,in some embodiments, a medicament delivery device can be moved between asimulation configuration and a medicament delivery configuration. Forexample, in some embodiments, a simulated medicament delivery device canbe configured to receive an actual medicament delivery device tosubsequently move from a simulation configuration to a medicamentdelivery configuration.

What is claimed is:
 1. An apparatus, comprising: a housing of asimulated medical injector, the simulated medical injector configured tosimulate an operation of an actual medical injector, the simulatedmedical injector devoid of a medicament or a delivery member such thatthe simulated medical injector is incapable of delivering themedicament; an electronic circuit system coupled to the housing, theelectronic circuit system including a speaker, the electronic circuitsystem configured to produce an audible output via the speaker when theelectronic circuit system is actuated; a contact member coupled to adistal end portion of the housing, the contact member configured tocontact a target location to simulate use of the actual medicalinjector; and a cover member movably coupled to the distal end portionof the housing, a first portion of the cover member disposed within thehousing and in contact with the electronic circuit system when the covermember is in a first position, a second portion of the cover memberdisposed about a portion of the contact member when the cover member isin the first position, the first portion spaced apart from theelectronic circuit system and the second portion spaced apart from thecontact member when the cover member is in a second position, the firstportion configured to actuate the electronic circuit system when thecover member is moved from the first position to the second position. 2.The apparatus of claim 1, wherein the simulated medical injector isconfigured to repeatedly simulate the operation of the actual medicalinjector.
 3. The apparatus of claim 1, wherein: the electronic circuitsystem includes a processor, a power source, and an electrical contactconfigured to electrically couple the power source to the processor; andthe first portion of the cover member is disposed between a terminal ofthe power source and the electrical contact when the cover member is inthe first position, the first portion being spaced apart from theterminal of the power source to electrically couple the processor to thepower source when the cover member is in the second position.
 4. Anapparatus, comprising: a container defining an internal regionconfigured to contain at least a portion of a medicament deliverydevice, the container including an electronic circuit system including aswitch, the electronic circuit system configured to receive an inputfrom at least one of a microphone or an electronic visual display, theelectronic circuit system configured to output a first electronic outputassociated with the input, the electronic circuit system configured tooutput a second electronic output associated with the medicamentdelivery device when the switch is moved from a first state to a secondstate, the container including a mounting portion configured to beremovably coupled to a structure, such that the container can be moved;and a movable member configured to be movably coupled to the container,the movable member configured to maintain the portion of the medicamentdelivery device within the internal region, a portion of the movablemember configured to move the switch from the first state to the secondstate when the movable member is moved relative to the container.
 5. Theapparatus of claim 4, wherein at least one of the first electronicoutput or the second electronic output is a wireless communicationssignal.
 6. The apparatus of claim 1, wherein: the audible output is afirst audible output; the contact member is configured to move relativeto the housing from a first actuator position to a second actuatorposition to simulate use of the actual medical injector; and theelectronic circuit system is configured to produce a second audibleoutput in response to the contact member moving from the first actuatorposition to the second actuator position.
 7. The apparatus of claim 6,wherein the contact member includes a protrusion configured to move aswitch of the electronic circuit system from a first state to a secondstate when the contact member is moved from the first actuator positionto the second actuator position, the electronic circuit system producingthe second audible output in response to the switch being moved from thefirst state to the second state, the contact member including a retainerconfigured to engage a retention portion of the housing to maintain thecontact member in the second actuator position, the contact memberconfigured to be reset back to the first actuator position to repeatedlysimulate the operation of the actual medical injector.
 8. The apparatusof claim 1, wherein the electronic circuit system includes a networkcommunication interface configured to transmit a wireless signal to aremote computing device, the wireless signal associated with a use ofthe simulated medical injector.
 9. The apparatus of claim 1, wherein theaudible output is a first audible output, the apparatus furthercomprising: a simulated needle guard removably coupled to the distal endportion of the housing, the simulated needle guard including a simulatedneedle sheath disposed through the contact member and within the housingwhen the simulated needle guard is coupled to the distal end portion ofthe housing, the simulated needle guard including a needle guardprotrusion configured to actuate the electronic circuit system when thesimulated needle guard is removed from the distal end portion of thehousing, the electronic circuit system configured to produce a secondaudible output when the simulated needle guard is removed from thedistal end portion of the housing.
 10. An apparatus, comprising: acontainer defining an internal region within which a medicament deliverydevice can be contained, the container including a retainer configuredto retain the medicament delivery device within the internal region; anelectronic circuit system coupled to the container, the electroniccircuit system including a first switch, a second switch, and an outputsystem, the electronic circuit system configured to produce a firstoutput via the output system in response to the first switch being movedfrom a first state to a second state, the electronic circuit systemconfigured to produce a second output via the output system when thesecond switch is actuated, the second output associated with themedicament delivery device, the second switch associated with theretainer such that when the medicament delivery device is decoupled fromthe retainer the second switch is actuated; and a movable member movablycoupled to the container, the movable member configured to cover theinternal region and maintain the medicament delivery device within theinternal region, a portion of the movable member configured to move thefirst switch from the first state to the second state when the movablemember is moved relative to the container.
 11. The apparatus of claim10, wherein the output system includes an audible output device and anetwork communication interface configured to transmit a wireless signalto a remote computing device, the first output and the second outputeach including one of an audible output produced by the audible outputdevice or the wireless signal produced by the network communicationinterface.
 12. The apparatus of claim 10, wherein: the medicamentdelivery device is an auto-injector; and the retainer is uniquelyassociated with the auto-injector.
 13. The apparatus of claim 10,wherein: the medicament delivery device is a first auto-injector from aplurality of auto-injectors; the retainer is a first retainer; thecontainer is configured to contain the plurality of auto-injectors, thecontainer including a second retainer configured to retain a secondauto-injector from the plurality of auto-injectors within the internalregion; and the electronic circuit system includes a third switchassociated with the second retainer such that when the secondauto-injector is decoupled from the second retainer the third switch isactuated.
 14. The apparatus of claim 10, wherein the retainer is atleast one of a clip, a recessed portion of the internal region, or anelastic member.
 15. The apparatus of claim 11, wherein at least one ofthe first output or the second output is a recorded speech outputproviding instructions associated with the medicament delivery, device.16. The apparatus of claim 12 wherein the auto-injector includesepinephrine.
 17. The apparatus of claim 10, wherein the second output isa wireless signal associated with at least one of an identification ofthe medicament delivery device or an expiration date of the medicamentdelivery device.
 18. The apparatus of claim 10, wherein the electroniccircuit system is configured to receive an input from at least one of amicrophone or an electronic visual display, the electronic circuitsystem configured to produce a third output via the output system, thethird output associated with the input.
 19. The apparatus of claim 10,wherein the container includes a mounting portion configured to beremovably coupled to a structure, such that the container can be moved.